1

 FY 2022

MCMi Program Update

FDA MEDICAL COUNTERMEASURES INITIATIVE
1

Contents

Background..............................................................................................................................................................................2

FY 2022 Resources for MCM Activities .................................................................................................................................. 3

Objectives, Activities & Achievements ....................................................................................................................................4

Medical Countermeasure Approvals....................................................................................................................................... 5

Supporting an Adequate Supply of Medical Countermeasures..............................................................................................8

Enabling Access to MCMs Under FDA’s EUA Authority.......................................................................................................10

Responding to Emerging Infectious Disease Public Health Threats ....................................................................................14

Action Teams ..........................................................................................................................................................................19

Regulatory Advice and Guidance ...........................................................................................................................................21

Collaboration and Communication.......................................................................................................................................24

Medical Countermeasure Regulatory Science ......................................................................................................................26

Advanced Manufacturing ......................................................................................................................................................33

Medical Countermeasure Regulatory Policy......................................................................................................................... 37

Professional Development.....................................................................................................................................................39

Appendix 1: FY 2022 Medical Countermeasure Approvals - Biologics and Drugs............................................................41

Appendix 2: FY 2022 Medical Countermeasure Approvals - Devices .............................................................................. 43

Appendix 3: MCM-Related Guidance Issued in FY 2022 .................................................................................................48

Appendix 4: Key MCM-Related Meetings Held in FY 2022 ............................................................................................. 53

Appendix 5: Acronyms .......................................................................................................................................................60

List of Tables

Table 1: FY 2022 resources obligated to MCM activities...................................................................................................... 3

Table 2: COVID-19 EUA recap.............................................................................................................................................10

Table 3: FY 2022 formal meetings between CBER/CDER and MCM sponsors or applicants.......................................... 22

Table 4: FY 2022 meetings between CDRH and MCM sponsors or applicants ................................................................ 23

Table 5: MCMi Regulatory Science Program activities in FY 2022 ...................................................................................30

List of Boxes

Box 1: Key FDA activities to facilitate development of and access to MCMs ....................................................................... 4

Box 2: Key FDA emerging threat response activities ...........................................................................................................14

Box 3: Featured collaborations............................................................................................................................................24

Box 4: MCM regulatory science research areas ..................................................................................................................28

Box 5: Featured MCMi-funded extramural projects...........................................................................................................29

Box 6: Featured regulatory science collaborations ............................................................................................................. 32

Box 7: Featured advanced manufacturing project: I-TEAM Hub....................................................................................... 33

Box 8: Featured advanced manufacturing project: Smart Design and Manufacturing Pilot ............................................ 34

Box 9: Strengthening the MCM supply chain .....................................................................................................................38

List of Figures

Figure 1: Summary of process for EUA issuance.................................................................................................................13

Figure 2: Coronavirus Treatment Acceleration Program (CTAP) dashboard ....................................................................15
2

BACKGROUND

FDA plays a critical role in protecting the 

U.S. from chemical, biological, radiological, 

and nuclear threats, and emerging 

infectious diseases, like COVID-19 and 

mpox. This report provides updates 

on FY 2022 activities agency-wide to 

support medical countermeasure-related 

public health emergency preparedness 

and response.

T

he United States (U.S.) Food and Drug Administration (FDA or agency) plays a critical role in 

protecting the U.S. from chemical, biological, 

radiological, nuclear (CBRN), and emerging infectious 

disease threats, such as Severe Acute Respiratory 

Syndrome Coronavirus 2 (SARS-CoV-2), the virus 

that causes coronavirus disease 2019 (COVID-19), 

and outbreaks including Ebola and mpox.1 FDA is 

responsible for reviewing the safety and effectiveness 

of medical countermeasures (MCMs)—including 

drugs, therapeutic biologics, vaccines, and devices, 

such as diagnostic tests—to counter these threats.2

In addition to its regulatory responsibilities, FDA 

works closely with U.S. government (USG) partners, 

to build and sustain the MCM programs necessary 

to effectively respond to public health emergencies.3

This includes the agency’s unprecedented COVID-19 

pandemic response efforts that began in December 

2019, and continue today. Interagency collaborations 

include numerous engagements through the U.S. 

Department of Health and Human Services (HHS) 

Public Health Emergency Medical Countermeasures Enterprise (PHEMCE, or the Enterprise). FDA 

also works closely with the U.S. Department of Defense 

(DoD) to facilitate the development and availability 

of MCMs to support the unique needs of American 

military personnel, including under a framework 

established in FY 2018 under Public Law 115-92 for 

enhanced FDA/DoD collaborations. FDA supports the 

PHEMCE and DoD by providing subject-matter expertise in MCM development and by providing scientific 

and regulatory input to inform MCM development, 

procurement, and stockpiling decisions. In addition, 

FDA facilitates access to available MCMs to respond 

to public health and military emergencies, even when 

products are still investigational or not yet approved for 

that particular use, provided certain criteria are met.

4,5

In 2010, FDA launched its Medical Countermeasures Initiative (MCMi) Program, building on the 

substantive MCM work ongoing at FDA. The Program 

1 In November 2022, the World Health Organization announced, and the USG supported, renaming monkeypox disease to mpox. 

This report refers to the disease as mpox, except where the term “monkeypox” is part of a product name, indication, guidance or 

policy title, or other proper name (such as web page titles) that had not yet been updated at the time of report compilation. 

2 MCMs include qualified countermeasures as defined in section 319F–1(a)(2)(A) of the Public Health Service Act (PHS Act) (42 

USC. § 247d–6a(a))(2)(A); qualified pandemic or epidemic products as defined in section 319F–3(i)(7) of the PHS Act (42 USC. § 

247d–6d(i)(7)); and security countermeasures as defined in section 319F-2(c)(1)(B) of the PHS Act (42 USC § 247d–6b(c)(1)(B)). 

Some medical products (e.g., traumatic brain injury (TBI) diagnostics), and some activities (e.g., combatting antimicrobial resistance) discussed in this report may not meet the statutory definition of MCMs or relate directly to products defined as MCMs, 

but were included in this report as examples of additional work supported by MCMi Program staff because of their connection to 

public health preparedness. Inclusion of such examples is not intended as comprehensive reporting on agency activities related 

to these topics.

3 Section 2811-1 of the PHS Act (42 U.S.C. 300hh-10a).

4 See e.g., sections 561 and 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

5 For purposes of this document, “approved” refers to “FDA-approved, licensed, or cleared” under sections 505, 510(k), 512, 515, or 

571 of the FD&C Act or section 351 of the PHS Act. For medical devices, the term “approval” is used generally to mean marketing 

under a premarket approval application (PMA), 510(k) notification, or De Novo classification.
3

focuses increased resources on promoting the development of MCMs by establishing clear regulatory 

pathways for MCMs, instituting effective regulatory 

policies and mechanisms to facilitate timely access 

to available MCMs, and advancing MCM regulatory 

science to create the tools that support timely 

regulatory decision-making.

Many of FDA’s activities under the MCMi Program 

foster the development and availability of MCMs, 

and FDA has also been given legal authorities

to enable the agency to more effectively support 

preparedness and response efforts. The Pandemic and 

All-Hazards Preparedness Reauthorization Act of 2013 

(PAHPRA)6 requires FDA to issue an annual report 

detailing its MCM activities. This report responds to 

that requirement for fiscal year (FY) 2022 

(October 1, 2021 – September 30, 2022).7

6 Public Law 113-5, 127 Stat. 161 (2014).

7 Detailed information on FDA’s MCM development and review activities covering FY 2011-2021 can be found at: 

https://www.fda.gov/emergency-preparedness-and-response/about-mcmi/publications-and-reports

FY 2022 RESOURCES FOR 

MCM ACTIVITIES

FDA obligated an estimated $498.15 million in FY 

2022 to support CBRN, COVID-19, and pandemic 

influenza-related MCM activities (Table 1). These 

resources comprised a combination of base funding 

and no-year funding. This funding supported 856.3 

full-time equivalents (FTEs).

Table 1: FY 2022 resources for MCM activities 

(dollars in millions)

FY 22 

Estimate

FY 22 

FTE 

Estimate

CBRN Base Funding $126.06 474.7

Pandemic Influenza 

Base Funding $28.83 93.1

MCMi Base Funding $36.55 110.5

Subtotal $191.44 678.3

COVID-19 Supplemental 

Funding $306.71 178.0

Total $498.15 856.3

What are medical countermeasures?

Medical countermeasures, or MCMs, are FDAregulated products, including biologics, drugs, and 

devices, that may be used in the event of a potential 

public health emergency stemming from a terrorist 

attack with a biological, chemical, or radiological/

nuclear material, or a naturally occurring emerging 

disease. MCMs can be used to diagnose, prevent, 

protect from, or treat conditions associated with 

chemical, biological, radiological, or nuclear threats, 

or emerging infectious diseases.
4

OBJECTIVES, ACTIVITIES 

& ACHIEVEMENTS

FDA’s overarching objective with respect to MCMs—

which cuts across all FDA centers and offices engaged 

in MCM activities—is to facilitate the timely development of and access to safe and effective MCMs to 

counter CBRN and emerging infectious disease threats 

for civilian populations, as well as MCMs to support 

American military personnel.8

The following sections provide detail on achievements in FY 2022 with respect to these activities.

8 An updated publicly available list of high-priority threats identified by the Enterprise for which MCMs are needed can be found 

in the PHEMCE Strategy and Implementation Plan 2022 (see Appendix B), published in October 2022.

Box 1: Key FDA activities to facilitate 

development of and access to MCMs 

Supporting developers, manufacturers, researchers, and 

others in development of new and innovative MCMs to 

meet FDA’s standards

Providing regulatory advice, guidance, and technical 

assistance to sponsors developing investigational 

MCMs for CBRN or emerging infectious disease threat 

indications

Discussing questions with potential product sponsors to 

help clarify requirements for approval or Emergency Use 

Authorization (EUA)

Reviewing MCM marketing applications and approving 

those that meet standards for approval 

Supporting the establishment and sustainment of an 

adequate supply of MCMs, including interagency 

collaboration on efforts to advance MCM supply chains

Enabling access to available MCMs that are not yet 

approved for use—when necessary—through an 

appropriate regulatory mechanism that may include an 

expedited approval pathway or EUA

Responding to emerging and re-emerging public 

health threats

Establishing and sustaining Public Health and Security 

Action Teams to identify and catalyze the resolution 

of regulatory and scientific challenges associated with 

MCMs to address high-priority threats

Developing capabilities to monitor and assess MCMs 

used during public health emergencies

Collaborating with USG partners developing MCMs

Sustaining the MCMi Regulatory Science Program to 

create tools, standards, and approaches to develop and 

assess MCM safety, efficacy, quality, and performance

Encouraging manufacturers to develop innovative and 

emerging approaches to produce medicines through 

advanced manufacturing technologies

Ensuring that the FDA legal, regulatory, and policy 

framework adequately supports MCM development 

and enables preparedness and response activities

Sustaining the MCMi professional development 

program to ensure that FDA personnel maintain the 

requisite skills and abilities to support the MCM mission
5

MEDICAL COUNTERMEASURE 

APPROVALS

During FY 2022, FDA continued to review marketing 

applications for MCMs against CBRN and emerging infectious disease threats and approve safe and 

effective MCMs. FDA approved the majority of MCM 

marketing applications under review9 in FY 2022 

(see Appendixes 1 and 2 for lists of FY 2022 MCM 

approvals). The agency also issued and amended 

numerous EUAs (see: Enabling Access to MCMs 

Under FDA’s Emergency Use Authorization 

Authority). 

MCMs to treat or prevent diseases or 

conditions caused by chemical threats

To help with preparedness of U.S. military personnel, 

in February 2022, FDA approved a New Drug 

Application (NDA) for a naloxone hydrochloride 

autoinjector for use by military personnel and chemical incident responders for emergency treatment 

of patients 12 years of age and older where use of 

high-potency opioids, such as fentanyl analogues, as 

a chemical weapon is suspected, and for temporary 

prophylaxis of respiratory and/or central nervous 

system depression in military personnel and chemical 

incident responders entering an area contaminated 

with high-potency opioids such as fentanyl analogues. 

In addition, in August 2022, FDA approved an 

NDA for the use of Midazolam Injection, 10 mg/0.7 

mL, autoinjector, indicated for the treatment of 

status epilepticus in adults. This indication could 

include seizures resulting from nerve agent exposure. 

DoD developed the product with Rafa Laboratories, 

Ltd. According to JPEO-CBRND (the U.S. Joint 

Program Executive Office for Chemical, Biological, 

Radiological and Nuclear Defense), the autoinjector 

“improves upon and will replace the currently fielded 

convulsant antidote for nerve agent (CANA) diazepam 

autoinjector.” The DoD’s Chemical and Biological 

Defense Program also supported this effort.

MCMs to diagnose, treat, or prevent COVID-19

In addition to activities noted in other sections of 

this report to enable access to investigational MCMs to 

diagnose, prevent, or treat COVID-19, FDA approved 

additional COVID-19 vaccines, therapeutics, and 

diagnostic tests in FY 2022. 

Vaccines

In January 2022, FDA approved the second COVID-19 

vaccine, Spikevax (COVID-19 Vaccine, mRNA) from 

ModernaTX, Inc., a monovalent COVID-19 vaccine for 

the prevention of COVID-19 in individuals 18 years of 

age and older as a two-dose series. Also known as the 

Moderna COVID-19 Vaccine, this vaccine has been 

available under EUA since December 18, 2020. 

In July 2022, FDA approved Comirnaty

(COVID-19 Vaccine, mRNA) for active immunization 

to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 through 15 years of age as a two-dose series. 

Also known as the Pfizer-BioNTech COVID-19 

Vaccine, this vaccine has been authorized for emergency use in this age group since May 2021. Comirnaty 

has been approved for use in individuals 16 years of 

age and older since August 2021. The Pfizer-BioNTech 

COVID-19 Vaccine has been available under EUA since 

December 2020. In December 2021, FDA approved

a manufacturing change for Comirnaty to include a 

9 For purposes of this document, “under review” indicates that a marketing application has been submitted to FDA for approval by 

the product’s sponsor.
6

formulation that uses a different buffer. Buffers help 

maintain a vaccine’s pH (a measure of how acidic or 

alkaline a solution is) and stability. This new formulation is more stable at refrigerated temperatures for 

longer periods of time, permitting greater flexibility for 

vaccination providers.

Therapeutics

In April 2022, FDA approved the expanded use of 

the first COVID-19 treatment, Veklury (remdesivir), to 

include young children. FDA approved the expanded 

use of Veklury to include pediatric patients 28 days of 

age and older weighing at least 3 kilograms (kg) (about 7 

pounds) with positive results of direct SARS-CoV-2 viral 

testing, who are hospitalized, or not hospitalized and 

have mild-to-moderate COVID-19 and are at high risk 

for progression to severe COVID-19, including hospitalization or death. Previously, Veklury was only approved 

to treat certain adults and pediatric patients (12 years of 

age and older who weigh at least 40 kg, which is about 

88 pounds) with COVID-19. The April 2022 action made 

Veklury the first approved COVID-19 treatment for 

children less than 12 years of age. Previously, in January 

2022, FDA approved Veklury for a three-day dosing 

regimen for the treatment of coronavirus disease 2019 

(COVID-19) in adults and pediatric patients (12 years of 

age and older and weighing at least 40 kg) with positive results of direct severe acute respiratory syndrome 

coronavirus 2 (SARS-CoV-2) viral testing, who are not 

hospitalized and have mild-to-moderate COVID-19, and 

are at high risk for progression to severe COVID-19, 

including hospitalization or death.

In May 2022, FDA approved Olumiant (baricitinib) for the treatment of COVID-19 in hospitalized 

adults requiring supplemental oxygen, noninvasive 

or invasive mechanical ventilation, or extracorporeal 

membrane oxygenation (ECMO).

Diagnostic tests

In November 2021, FDA cleared a 510(k) for a SARSCoV-2 test. The BioFire COVID-19 Test offered 

under an EUA since March 2020, is the second SARSCoV-2 diagnostic test granted marketing authorization 

that permits the test to be marketed beyond the public 

health emergency.10 In July 2022, FDA cleared an 

additional 510(k) for the BioFire COVID-19 

Test 2 to display results for four additional SARSCoV-2 assays which were present on the test, but for 

which results were masked through software. The 

assays were unmasked as a mitigation against the risk 

of future SARS-CoV-2 variants affecting the sensitivity 

of the test due to mutations in assay primer regions. 

In September 2022, FDA cleared a 510(k) for 

a SARS-CoV-2 test, the Simplexa COVID-19 

Direct, Simplexa COVID-19 Positive Control 

Gen II Pack. Development of this test, which has 

been offered under an EUA since March 2020, was 

supported by the Biomedical Advanced Research and 

Development Authority (BARDA). 

MCMs to diagnose, treat, or prevent 

smallpox and mpox

Following reports of mpox in the U.S. in late May 

2022, FDA worked with BARDA to expedite the 

submission of a manufacturing supplement to FDA 

to facilitate production of an FDA-licensed vaccine 

at an additional site that was originally planned for 

Fall 2022. In September 2022, FDA approved a 

BLA supplement for the Jynneos Smallpox and 

Monkeypox Vaccine, Live, Non-Replicating, 

which allowed additional doses manufactured at a 

10 The first FDA-cleared SARS-CoV-2 diagnostic test was granted marketing authorization in March 2021, using the De Novo 

premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. 
7

facility in Europe to be further distributed and administered in the U.S. to help address the mpox outbreak. 

The expedited inspection and approval of Bavarian 

Nordic’s fill-and-finish capabilities enabled an 

additional 786,000 doses of vaccine to be made 

available for use in the U.S. Given the emerging public 

health need, FDA facilitated advance shipments of 

manufactured doses to the U.S. for prepositioning so 

that they would be onshore and ready to be distributed 

once FDA completed inspection and approved the 

manufacturing changes.

Also supporting smallpox and mpox preparedness, 

in May 2022, FDA approved an intravenous (IV) 

formulation of TPOXX (tecovirimat) for the treatment 

of human smallpox disease caused by the variola virus 

in adults and pediatric patients weighing at least 

3 kg. The oral formulation of the drug was originally 

approved in 2018. The IV formulation is an option 

for those who are unable to swallow the oral capsule, 

and this approval expanded the eligible population 

from patients weighing at least 13 kg down to patients 

weighing at least 3 kg. Like the original NDA, this 

approval was granted under the Animal Rule.

Since the first case of mpox was detected in the 

U.S., FDA has been working closely with the Centers 

for Disease Control and Prevention (CDC), laboratories, and commercial manufacturers to support test 

development and help make tests more readily available to consumers who need them. The CDC also has 

an FDA-cleared real-time polymerase chain reaction 

(PCR) test that detects non-variola Orthopoxvirus 

DNA, including the virus that causes mpox. The CDC 

test was cleared in 2018 (K181205) for in vitro qualitative presumptive detection of non-variola Orthopoxvirus DNA extracted from human pustular or vesicular 

rash specimens and viral cell culture lysates submitted to a CDC Laboratory Response Network (LRN) 

reference laboratory. In 2022, FDA cleared additional 

510(k)s from CDC, which expanded testing capacity 

through use:

• of additional reagents and automation 

(K221658; cleared on June 10, 2022),

• in CDC-designated laboratories outside the LRN 

(K221834; cleared on June 24, 2022), and

• of new extraction platform options, among other 

changes (K222558; cleared on August 30, 2022).

MCMs to treat or prevent diseases or 

conditions caused by other emerging 

infectious diseases

To support Ebola preparedness, in September 2022, 

FDA approved a Biologics License Application (BLA) 

supplement for Ervebo (Ebola Zaire Vaccine, Live), to 

revise the package insert based upon Study V920-018 

conducted in frontline workers. 

Pandemic influenza preparedness

To support pandemic influenza preparedness, FDA 

extended the eligible population for certain vaccines 

and therapeutics. In October 2021, FDA approved a 

About the Animal Rule

Before a medical product can be approved by 

FDA, the sponsor must prove the product’s safety 

and effectiveness for its intended use. FDA has 

regulations, commonly known collectively as the 

Animal Rule, that allow, under very limited circumstances, FDA to rely on evidence of effectiveness 

from adequate and well-controlled studies 

conducted in animal models of the disease or 

condition of interest when human efficacy studies 

are not ethical or feasible and when the results 

of those animal studies establish that the product 

is reasonably likely to produce clinical benefit 

in humans. The product sponsor must still 

demonstrate the product’s safety in humans. 

The Animal Rule can be used only for drug and 

biological products that have been studied for their 

safety and efficacy in preventing or ameliorating 

serious or life-threatening conditions caused 

by exposure to lethal or permanently disabling 

toxic chemical, biological, radiological, or nuclear 

substances when definitive human efficacy studies 

cannot be conducted because:

1) it has not been feasible to study the product’s 

effectiveness after accidental or hostile 

exposure, and 

2) it would not be ethical to deliberately expose 

healthy human volunteers to the substance.

The Animal Rule also only applies to products 

that cannot be approved through other existing 

regulatory pathways.
8

BLA supplement for Flucelvax Quadrivalent

influenza vaccine to extend its use to individuals 

down to 6 months of age for the prevention of 

influenza disease. In August 2022, FDA approved a 

supplemental NDA for Xofluza (baloxavir marboxil) 

for the treatment of influenza and for post-exposure 

prophylaxis of influenza in a new population, pediatric 

patients ≥ 5 to less than 12 years of age. 

FDA also cleared two new influenza diagnostic tests 

in FY 2022. These steps forward in influenza prevention and diagnostics facilitate preparedness for both 

seasonal and pandemic influenza, as new tests and 

technologies may be applied more rapidly to emerging 

pandemic influenza strains once approved for seasonal 

influenza use.

All-hazards preparedness

For preparedness in the event of a large-scale event 

involving thermal burns, FDA cleared two products. 

In February 2022, FDA cleared Zeolite Hemostatic 

Gauze, intended to be used for temporary external 

use to control traumatic bleeding. In May 2022, 

FDA cleared the MYO1 Continuous Compartmental 

Pressure Monitor. This monitor is used for real-time 

measurement of the muscle compartment pressure 

to aid in the diagnosis of compartment syndrome

(acute and chronic).

Additional marketing applications in progress 

Sixteen additional marketing applications for new 

MCMs or new MCM indications were under review in 

FY 2022; these reviews were still ongoing at the end 

of the reporting period for this report. While FDA 

anticipates meeting the goal date for a decision for 

each of these submissions, FDA is generally prohibited 

from disclosing any determinations regarding the 

filing or approvability of any marketing application 

for a medical product under applicable statutory 

and regulatory provisions unless the application is 

approved or other grounds for disclosure apply.

SUPPORTING AN 

ADEQUATE SUPPLY 

OF MEDICAL 

COUNTERMEASURES

In addition to actively monitoring the medical product 

supply chains, FDA continued efforts to support supplies 

of MCMs in other ways during FY 2022. 

Preventing and mitigating shortages

Working to resolve MCM shortages as quickly as 

possible when they occur is another way FDA helps 

ensure an adequate supply of MCMs. In addition to 

extensive COVID-19-related supply chain monitoring 

and mitigation activities, in FY 2022, FDA continued 

to collaborate with USG partners and manufacturers 

of autoinjector products used for the treatment of 

nerve agent and insecticide poisoning to help prevent 

shortages of these products. FDA continues to review 

applicable scientific data, including through the ShelfLife Extension Program (SLEP), to assess whether, 

if properly stored, certain lots of autoinjector products held for emergency use can continue to be used 

beyond the original labeled expiration date for a period 

specified by FDA, to help ensure ready access to these 

products. FDA also reviewed scientific data to assess 

whether certain lots are no longer useable and, 

therefore, should be properly disposed of.

FDA also responded to numerous stakeholder 

inquiries on nerve agent autoinjector expiry dating 

extensions to assist in determinations about 

whether stockpiled autoinjector products made 

by the same manufacturer should be retained. 

Meanwhile, FDA continued to work with the applicant 

on manufacturing issues.

Extending expiration dates

To help ensure an adequate supply of MCMs for 

potential emergencies, FDA may extend the expiration 

dating of MCMs based on FDA’s review of scientific 

data. For example, in 2019, FDA issued final guidance

to support government public health and emergency 
9

To help ensure an adequate supply of 

MCMs for potential emergencies, FDA 

may extend the expiration dating of MCMs 

based on FDA’s review of scientific data.

response stakeholder testing to support FDA extensions 

of the expiration date of specific lots of doxycycline 

hyclate 100 mg capsules held in strategic stockpiles 

for anthrax emergency preparedness and response 

purposes. Based on government stakeholder needs, 

FDA continues to review scientific data to determine 

whether additional extensions of other MCMs may be 

supported outside of the SLEP. 

Vaccines and biological therapeutics authorized 

for emergency use—as products that are not approved 

under a BLA and are still being studied under Investigational New Drug applications (INDs)—do not have fixed 

expiry dates. For those doses that are close to expiry, 

if they are being held under appropriate conditions for 

ensuring their integrity for use, they can potentially 

be quarantined to see if data on new stability studies 

warrant extension of the initial expiry date according 

to appropriate policies and procedures. In FY 2022, 

FDA extended the expiration date of several lots of 

Pfizer-BioNTech COVID-19 Vaccine, Janssen COVID-19 

Vaccine, and several COVID-19 therapeutics including 

Paxlovid and five monoclonal antibodies (mAbs).

Reagent stability studies are needed to support 

shelf-life expiration dates for in vitro diagnostics 

(IVDs) authorized under an EUA for emergency use 

during the COVID-19 pandemic; however, they generally do not need to be completed at the time of initial 

review of the EUA request and/or EUA issuance, but 

should be initiated immediately following authorization, if not before. In the absence of real-time stability 

data, initial reagent stability claims typically do not 

exceed a four-to-six-month expiration date. Following initial FDA authorization, FDA has extended and 

authorized shelf-life expiration dates after reviewing 

real-time data generated by the IVD manufacturer. 

Shelf-life expiration dates have been extended 

multiple times as additional data becomes available. 

When shelf-life expiration dates are extended for 

devices that have already been distributed, the IVD 

manufacturer typically sends a notice to customers to 

inform them of the extension so they are aware of 

how long they can continue to use in-stock devices. 

In FY 2022, FDA extended the shelf life of 13 at-home 

over-the-counter (OTC) COVID-19 diagnostic tests, 

and continually updates the list for easy reference 

by consumers. 

FDA also continued to support SLEP, a federal 

fee-for-service program for extending the useful shelf 

life of military-significant and contingency use medical 

products, including MCMs that are owned by components of DoD or other federal program participants 

such as the Strategic National Stockpile (SNS). 

SLEP is designed to defer drug replacement costs for 

date-sensitive stockpiles of drugs by extending their 

useful shelf life beyond the manufacturer’s original 

labeled expiration date. FDA laboratory personnel test 

and evaluate drugs submitted for shelf-life extension 

to ensure stability and quality before an expiry dating 

extension is granted. In FY 2022, as a result of SLEP 

testing that ensured drug stability and quality, FDA 

granted shelf-life extensions for approximately 1,085 

lots (batches) of MCM drugs.
10

ENABLING ACCESS TO 

MCMS UNDER FDA’S 

EMERGENCY USE 

AUTHORIZATION AUTHORITY

During FY 2022, FDA continued to work with USG 

partners, including DoD and other PHEMCE partners, 

and product sponsors to enable access to unapproved 

MCMs when necessary.11 One way FDA does this is 

by issuing EUAs. The EUA authority12 allows FDA to 

authorize the use of an unapproved medical product, 

or the unapproved use of an approved medical 

product, in anticipation of a potential emergency or 

during an actual emergency involving CBRN agents, 

or, for DoD purposes, other agents that may cause, 

or are otherwise associated with, an imminently 

life-threatening and specific risk to U.S. military 

forces, if certain statutory criteria are met.13 Lists of 

current EUAs are published on the FDA website.

COVID-19 EUAs

Recognizing the urgent need for safe and effective 

COVID-19 MCMs, FDA continues to use its authorities 

and expertise to facilitate the expeditious development and availability of vaccines, therapeutics, and 

devices that have met the agency’s rigorous sciencebased standards for quality, safety, and effectiveness. 

As noted in Table 2, in FY 2022, FDA issued 66 new 

EUAs to support COVID-19 response. Cumulatively, 

from 2020 through the end of FY 2022, FDA issued 

569 EUAs, enabling access to thousands of products.

New COVID-19 EUAs issued in FY 2022 include:

• Evusheld (tixagevimab co-packaged with 

cilgavimab and administered together), the first 

monoclonal antibody for pre-exposure prevention of COVID-19 in certain individuals, including 

those with moderate to severely compromised 

immune systems

• Paxlovid (nirmatrelvir tablets and ritonavir 

tablets, co-packaged for oral use), the first oral 

antiviral for treatment of mild to moderate 

COVID-19 in certain adults and pediatric patients 

who are at high risk for severe COVID-19

• Lagevrio (molnupiravir), an additional oral 

antiviral for treatment of mild to moderate 

11 This support includes numerous activities including availability of pre-IND consultations for drug development proposals and 

pre-market consultations for device development proposals, advice, and feedback on clinical trial preparation, discussions 

related to expanded access protocols and pre-EUA discussions.

12 Section 564 of the FD&C Act (21 USCS § 360bbb-3)

13 The Project BioShield Act of 2004 [PL 108-276] established section 564 of the FD&C Act, granting the Secretary of HHS the 

authority to declare that circumstances exist that justify the authorization of “emergency use” of unapproved MCMs, or unapproved uses of approved MCMs, under certain terms and conditions. The authority to issue EUAs, after the declaration by the 

Secretary that issuance of such EUAs is justified, was delegated to the FDA Commissioner. Section 564 of the FD&C Act was 

amended by PAHPRA in 2013, the 21st Century Cures Act (Cures Act) in 2016 [PL 114-255], and PL 115-92 in 2017.

Table 2: COVID-19 EUA recap

Product type New 

EUAs

issued in 

FY 2022

Total 

EUAs 

issued 

since 

2020*

In vitro diagnostics 61 486

Drugs and biological 

therapeutics 4 17

Vaccines 1 4

Other devices** 0 62

Total 66 569

*This total may include EUAs that are no longer active 

(i.e., EUAs that have been revoked or terminated).

**Multiple devices were authorized for use under a single “umbrella” 

EUA in some cases, including certain tests, PPE, and ventilators/

accessories. Each umbrella EUA is counted here as a single EUA; 

while there were no new umbrella EUAs in FY 2022, additional 

products (e.g., surgical masks) were made available under such 

EUAs issued in previous years.
11

COVID-19 in certain adult patients who are at high 

risk for severe COVID-19

• Bebtelovimab, a new monoclonal antibody for 

the treatment of mild to moderate COVID-19 that 

retained activity against a number of variants/

subvariants circulating during FY 2022

• InspectIR COVID-19 Breathalyzer, the first 

COVID-19 diagnostic test that detects chemical 

compounds in breath samples associated with a 

SARS-CoV-2 infection

• Laboratory Corporation of America 

(Labcorp) VirSeq SARS-CoV-2 NGS Test, 

the first COVID-19 test to identify specific 

SARS-CoV-2 lineages

• Novavax COVID-19 Vaccine, Adjuvanted, 

an additional vaccine for the prevention of 

COVID-19 caused by SARS-CoV-2 in individuals 

12 years of age and older (after initial authorization for ages 18 and older) 

FDA modifies or amends EUAs as needed, including 

EUA amendments, and revisions to documentation 

including fact sheets and instructions for use. Multiple 

revisions were made to COVID-19 vaccine, therapeutic, 

and device EUAs in FY 2022—a substantial and ongoing 

effort. The latest information is available on the FDA 

website. For example, FDA:

• Authorized use of Moderna COVID-19 Vaccine 

as a two-dose series for individuals down to 6 

months of age.

• Authorized use of Pfizer-BioNTech COVID-19 

Vaccine as a two-dose series for children ages 5 

through 11.

• Authorized use of Pfizer-BioNTech 

COVID-19 Vaccine as a three-dose series for 

children 6 months through 4 years of age.

• Authorized bivalent formulations of the 

Moderna and Pfizer-BioNTech COVID-19 Vaccines 

for use in certain age groups as a single booster 

dose at least two months following primary or 

booster vaccination.

• Continued to closely monitor MCM use under EUAs, 

and when needed, amended EUAs to reflect updated 

safety information and requirements, and limit use 

or distribution (for example, due to reduced product 

activity against circulating variants). 

• Continued efforts to communicate with health 

care providers and consumers important 

information about products under EUA. Examples 

include providing information to help prescribers 

evaluate potential drug interactions when 

using Paxlovid therapy for COVID-19, and 

helping consumers find extended expiration dates 

for at-home OTC COVID-19 diagnostic tests.

• Authorized 1,125 revisions to COVID-19 IVD 

EUAs from March 2020 through September 2022. 

FDA may also revoke an individual EUA prior to the 

termination of the EUA declaration supporting it if:

1. Circumstances justifying issuance no longer exist, 

2. The criteria for its issuance are no longer met, or 

3. Other circumstances make revocation appropriate 

to protect the public health or safety.

Examples of circumstances that may make revocation 

appropriate to protect the public health or safety 

are described in the FDA Guidance Document: Emergency Use Authorization of Medical Products 

and Related Authorities. In FY 2022, FDA revoked 

EUAs for two COVID-19 therapeutics, and 3o IVDs. 

In addition, FDA delisted six IVDs from Appendix A 

of the EUA for Molecular Diagnostic Tests for 
12

SARS-CoV-2 Developed And Performed By 

Laboratories Certified Under CLIA To Perform 

High Complexity Test.

mpox EUAs

In addition to the extensive EUA work ongoing in 

response to COVID-19, in August 2022, FDA authorized Jynneos (Smallpox and Monkeypox Vaccine, 

Live, Non-Replicating) for: 1) active immunization by 

subcutaneous injection (two 0.5 mL doses four weeks 

apart) for prevention of monkeypox disease in individuals less than 18 years of age determined to be at high 

risk for monkeypox infection; and 2) active immunization by intradermal injection (two 0.1 mL doses four 

weeks apart) for prevention of monkeypox disease in 

individuals 18 years of age and older determined to be 

at high risk for monkeypox infection. FDA approved

Jynneos in 2019 for the prevention of smallpox and 

monkeypox disease in adults 18 years of age and older 

determined to be at high risk for smallpox or monkeypox infection. Jynneos is approved for administration 

subcutaneously (beneath the skin), as a two-dose 

series, four weeks apart. The 2022 EUA was expected 

to increase the total number of doses available 

for use in these populations by up to five-fold. 

In addition, in September 2022, FDA authorized

the first EUA for an IVD to detect the virus that causes 

mpox (Quest Diagnostics Monkeypox Virus Qualitative Real-Time PCR), and published guidance and 

templates for test developers, among other actions

to help expand access to testing. 

Pre-EUAs

In addition to issuing EUAs when necessary, FDA 

engages in the ongoing pre-EUA submission processes 

where FDA works with product sponsors or government agencies, such as the CDC and DoD, to facilitate the development of pre-EUA packages that may 

form the basis of an EUA request and issuance when 

the statutory criteria are met. During FY 2022, FDA 

continued to work with USG partners and industry on 

pre-EUA activities for MCMs against a diverse array 

of threats, in addition to intensive COVID-19 response 

efforts. For example, in FY 2022, the Center for 

Devices and Radiological Health (CDRH) received 257 

pre-EUA requests for IVDs; 197 for COVID-19; and 60 

for mpox. The same team handled a total of 

263 pre-EUA requests in the same period: 234 for 

COVID-19 IVDs, and 29 for mpox IVDs. CDRH also 

received 49 pre-EUA requests for non-IVD devices.

EUA transparency

FDA continues, to the extent appropriate and permitted by law, to publicly post reviews of scientific data 

and information supporting the issuance, revision or 

revocation of EUAs for all drug and biological products, including vaccines, as part of our response 

to COVID-19 and other public health emergencies, 

including mpox.

Consistent with FDA’s longstanding practice of posting the relevant scientific reviews after new drug and 

biological product approvals, FDA discloses information 

from EUA review documents as appropriate after the 

disclosure review and process is complete. As a part of 

this process, FDA may redact certain information that is 

protected from disclosure under the law. The redacted 

information may vary depending on the type of data 

contained in the reviews and whether the requestor 

consents to the release of information that is protected 

from disclosure under the law.

Data and information supporting EUA issuance of 

What is a pre-EUA?

To help prepare for potential and current emergencies, FDA works with MCM developers to prepare 

pre-EUA packages, when appropriate. A pre-EUA 

package contains data and information about the 

safety, quality, and effectiveness of the product, 

its intended use under a future or current EUA, 

and information about the emergency or potential 

emergency situation. 

The pre-EUA process allows FDA scientific and 

technical subject matter experts to begin a review 

of information and assist in the development of 

conditions of authorization, fact sheets, and other 

documentation that would be needed for an EUA 

in advance of an emergency, and helps facilitate 

complete EUA requests during a current emergency

declaration. A pre-EUA can only transition to an 

EUA if there is a current applicable emergency 

determination and declaration under Section 564 

of the FD&C Act. Learn more in the guidance 

Emergency Use Authorization of Medical 

Products and Related Authorities. 
13

Figure 1: Summary of process for EUA issuance

A text description of this chart is available on the FDA website: Summary of Process for EUA Issuance

Note: A determination under section 319 of the PHS Act that a public health emergency exists, such as the one issued on January 31, 

2020, does not enable FDA to issue EUAs. A separate determination and declaration are needed under section 564 of the FD&C Act to enable 

FDA to issue EUAs, provided other statutory criteria are met. For more information, see: FAQs: What happens to EUAs when a public 

health emergency ends?

IVDs is included in the Instructions for Use or EUA 

Summary documents, which are published for every 

IVD EUA. In addition, in October 2021, FDA publicly 

posted information about an independent third-party 

assessment of the EUA process CDRH implemented to 

help authorize COVID-19 tests during the public health 

emergency. 
14

RESPONDING TO EMERGING 

INFECTIOUS DISEASE PUBLIC 

HEALTH THREATS

During infectious disease outbreak and epidemic 

and pandemic responses, FDA works proactively 

with U.S. government partners, medical product 

developers, and international partners (including the 

World Health Organization (WHO) and international 

regulatory counterparts) to provide scientific and 

regulatory advice to help facilitate the development 

and availability of MCMs.

In addition to responding to specific threats, 

including COVID-19, Ebola, and mpox, FDA also 

engages in numerous activities to support public 

health emergency preparedness for a variety of threats; 

typical activities to support such responses are noted 

in Box 2.

Box 2: Key FDA emerging threat response activities

Collaborating closely with HHS, other federal agencies, and international partners in preparedness and response decisions 

regarding MCM development and use

Providing review and feedback on MCM development proposals including clinical trial design and data assessment

Maintaining contact with drug, vaccine, and device (including diagnostic test) developers, and expediting the regulatory 

review of data for products that are currently in the pipeline and products that are still very early in development

Advising on design and set-up of clinical trials for establishing the safety and effectiveness of investigational products for 

the treatment and/or prevention of emerging infectious diseases, including COVID-19, Ebola, and Zika

Supporting FDA’s ongoing efforts to protect the safety of the nation’s blood supply and human cells, tissues, and cellular 

and tissue-based products (HCT/Ps) for transplantation

Enabling access to investigational MCMs—when necessary—through an appropriate mechanism such as under an 

expanded access protocol or for emergency use under an EUA, including review of expanded access protocols that may 

be used in Ebola outbreaks when a suitable clinical trial is not available, and updating EUA information for Zika and Ebola 

diagnostics that have not yet met requirements for full marketing clearance

Addressing issues related to the import and export of investigational MCMs

Preparing to implement safety surveillance programs for adverse events associated with MCM use and take appropriate 

action if safety issues are identified

Monitoring the MCM supply chain to identify product shortages and distribution of misbranded/counterfeit products

Monitoring false product claims, and taking appropriate action when necessary to protect consumers

Engaging with partners on innovative approaches to respond to public health emergencies as quickly and safely as 

possible

Communicating proactively and frequently with consumers, health care providers, and other stakeholders, including 

correcting misinformation whenever possible

Addressing health disparities and promoting health equity in preparedness and response to public health emergencies
15

In addition to preparedness and response activities 

noted in Box 2, FDA engaged in emerging infectious 

disease-specific response activities in FY 2022, 

including:

COVID-19

The COVID-19 pandemic is unprecedented in modern 

history and has required an extraordinary response 

around the world. On January 31, 2020, the HHS Secretary issued a determination

that a public health emergency exists, and the WHO 

declared COVID-19 a worldwide pandemic on March 11, 

2020. Since December 2019, 

and throughout the remainder of FY 2020-2022—and 

beyond—thousands of FDA 

scientists, clinicians, lawyers, and other experts have 

worked tirelessly to respond to COVID-19.

A July 2022 report issued by FDA, FDA’s Work 

to Combat the COVID-19 Pandemic, outlines 

much of the broad range of work FDA is undertaking to combat the COVID-19 pandemic and prepare 

for future emergencies. While a wide range of work 

continues across FDA to support COVID-19 response, 

this MCMi report offers a snapshot of MCM-related 

COVID-19 response activities during the FY 2022 

reporting period, including:

• Facilitating development of MCMs to diagnose, 

prevent, or treat COVID-19, including by working 

with medical product sponsors to clarify regulatory and data requirements necessary to rapidly 

advance development of products essential to 

supporting response efforts. In FY 2022, FDA 

approved a new vaccine and expanded the population eligible for a previously approved vaccine to 

include individuals ages 12 through 15; approved 

the first COVID-19 treatment for young children; 

and cleared two diagnostic tests (see: MCMs to 

diagnose, treat, or prevent COVID-19). 

• Enabling access to emergency use and investigational MCMs including accurate and reliable diagnostics through an appropriate mechanism, such 

as EUAs or INDs. (See Table 2: COVID-19 EUA 

recap). For example, in FY 2022, FDA:

◦ Received 35 new INDs for COVID-19 biological 

products, including 13 vaccines; 28 pre-INDs 

for COVID-19 biologics, including 23 vaccines; 

and authorized 20 Emergency Investigational 

New Drug Applications (EINDs) for biological 

products.

◦ Received 40 new pre-INDs and 50 new INDs for 

COVID-19 drugs, and authorized 453 EINDs for 

COVID-19 drugs. 

◦ Approved more than 1,700 COVID-19-related 

Abbreviated New Drug Application (ANDA) 

approvals (since 2020), including critical 

medications that have been in shortage due to 

their use in treating patients with COVID-19.

◦ Reviewed more than 450 clinical trials under the 

Coronavirus Treatment Acceleration Program 

(CTAP), a special emergency program launched 

in April 2020 for possible coronavirus therapies.

◦ Issued 61 new EUAs and 484 revisions to 

current EUAs for COVID-19 IVD devices.

Figure 2: Coronavirus Treatment Acceleration 

Program (CTAP) dashboard

As of September 30, 2022. The CTAP dashboard is updated

monthly.
16

• Actively monitoring the medical product and food 

supply chains to address imbalances. FDA continues to screen and monitor millions of domestic and 

international products in the medical supply chain 

to help ensure COVID-19-related supplies coming 

into the U.S. are safe and distributed appropriately. 

• Protecting consumers against fraudulent products, 

including issuing warning letters to companies 

selling unapproved and misbranded COVID-19 

countermeasures. 

• Providing continuous support for the USG initiative to distribute COVID-19 OTC test kits to households across the U.S. For example, FDA helped 

provide established processes for inspection of 

the test kits received to ensure that products were 

EUA-authorized, provided up-to-date information 

to ensure that test kits met specifications, and 

helped identify and resolve potential program risks.

• Conducting and collaborating on regulatory 

science research to help ensure FDA’s ability 

to quickly assess safety and efficacy of new 

SARS-CoV-2 MCMs, and to help diagnostic test 

developers validate and ensure the quality and 

performance of their tests. 

• Collaborating with USG partners and academia to 

design a comprehensive study to assess at-home 

COVID-19 antigen IVD test performance and 

evaluate the benefits of serial testing. Results of 

the study, funded by the NIH Rapid Acceleration 

of Diagnostics (RADx) program, will be made 

available as a resource to all at-home COVID-19 

antigen test manufacturers. This study resulted in 

an August 2022 safety communication to help 

consumers reduce the risk of false negative results.

mpox

FDA is also closely monitoring the U.S. mpox outbreak 

that began in 2022, and working to help ensure the 

development and availability of safe and effective 

MCMs to address this public health emergency. 

Although Jynneos Vaccine is approved for the 

prevention of smallpox and monkeypox disease in 

adults 18 years of age and older determined to be at 

high risk for smallpox or monkeypox infection, as of 

September 30, 2022, there are no FDA-approved or 

authorized therapeutic treatments for mpox disease. 

However, FDA continues to work closely with sponsors 

interested in developing and implementing protocols to generate safety and efficacy information while 

facilitating access. NIAID has opened a randomized, 

Wastewater Surveillance for 

SARS-CoV-2 Variants

Studies have shown that SARS-CoV-2 variants 

of concern from wastewater can be identified one 

to two weeks prior to being detected in clinical 

samples from the same area, making wastewater 

surveillance useful for detecting and monitoring 

SARS-CoV-2 in the population. 

Through the American Rescue Plan Act of 2021, 

Congress provided temporary funding for FDA to 

develop the capacity to sequence SARS-CoV-2 

RNA from wastewater samples and to conduct a 

sampling and sequencing project through 2022. 

By monitoring population-level variants over time, 

GenomeTrakr labs are providing information 

about the evolution of the virus, which is critical 

to evaluating the effectiveness of FDA-regulated 

COVID-19 vaccines, therapeutics, and diagnostics.

The software FDA developed to analyze sequences obtained from wastewater samples has been adopted by 

other public health partners, including the CDC. Raw sequence data plus a standard suite of metadata is

available for download.
17

mpox virus. Credit: NIAID

controlled clinical trial to assess the safety and 

efficacy of TPOXX (tecovirimat), an antiviral medication, for treatment of mpox disease, and CDC has an 

expanded access protocol available for patients meeting 

certain specified criteria who are not able to enroll in 

the randomized trial. In 2018, FDA approved TPOXX 

for treatment of smallpox in adults and children. 

Because smallpox is eradicated globally, FDA approved 

TPOXX under the Animal Rule, as it was neither ethical 

nor feasible to test the efficacy of the drug in humans. 

Safety data was obtained in healthy human volunteers without a smallpox or mpox infection. 

Unlike smallpox, mpox was endemic in other parts 

of the world (e.g., the Democratic Republic of the 

Congo [DRC]) at the time of TPOXX’s initial approval. 

Consequently, it remained both ethical and feasible to 

conduct clinical trials in humans to study TPOXX for 

the treatment of mpox disease. Therefore, TPOXX for 

the treatment of mpox disease was not appropriate for 

approval under the Animal Rule.

In May 2022, FDA approved an IV formulation of TPOXX for the treatment of smallpox in adults 

and children. The IV formulation provides a treatment 

option for individuals who are unable to swallow the 

oral capsule.

FDA continues to release updated safety information about mpox MCMs as needed, including, in 

September 2022, information for the scientific 

community on the risk of viral resistance to TPOXX, 

and a July 2022 safety communication advising 

people to use swab samples taken directly from a lesion 

(rash or growth) when testing for the monkeypox virus. Ebola virus. Credit: NIAID

In addition to vaccine and diagnostic approvals 

and EUAs noted earlier, FDA is working closely with 

the CDC to increase accessibility of its FDA-cleared 

test (see: MCMs to diagnose, treat, or prevent

smallpox and mpox), and with the diagnostic 

community to augment access to accurate testing to 

support the response. FDA continues to work closely 

with product sponsors to clarify regulatory and data 

requirements necessary to rapidly advance development and availability of additional medical products 

essential to supporting response efforts.

Ebola

FDA continued to support the international response 

to outbreaks of Ebola virus disease, including 

follow-up activities related to the 2014-2016 West 

Africa outbreak and ongoing response to the most 

recent outbreaks in Guinea, DRC, and Uganda 

continuing into 2022. In FY 2022, FDA:

• Continued to work closely with interagency 

partners, medical product developers, the WHO, 

and international regulatory counterparts to help 

move candidate medical products for Ebola—

including Sudan ebolavirus (SUDV)—forward in 

development as quickly as possible. 

◦ For example, FDA had previously participated in 

discussions of potential clinical trial approaches, 

including a trial comparing several investigational therapeutics against a control arm that 

began in 2018 and provided information helping 

to support approval of two monoclonal antibody 

therapies for Zaire ebolavirus disease. Based on 

this NIH trial and other experience with clinical 
18

trials in outbreak circumstances, FDA has continued to provide regulatory guidance to product 

developers. FDA also provided to WHO study 

recommendations for the evaluation of rapid 

Ebola antigen-based diagnostic tests to facilitate 

data collection for future marketing submissions.

◦ Unfortunately the results of therapeutic trials in 

previous outbreaks caused by Zaire ebolavirus

cannot be directly applied to the September 

2022 Uganda, Mubende District Sudan ebolavirus outbreak because these are two different viral 

species that cannot be assumed to respond in the 

same way to the same treatments. FDA continues 

to discuss clinical trial approaches with potential 

sponsors to encourage appropriate investigations 

to assess safety and efficacy of candidate products 

while facilitating access where needed.

• Continued work to facilitate access to available 

medical products through appropriate regulatory mechanisms when necessary and to protect 

consumers from fraudulent products and false 

product claims related to Ebola. 

• Continued to work with manufacturers of 

authorized Ebola diagnostics to make rapid tests 

available, as well as advance these products 

toward market approval. 

• Continued extramural research to expand a 

biobank of plasma and peripheral blood mononuclear cell (PBMC) samples to help support the 

development of MCMs against Ebola virus.

Tularemia 

Tularemia is a potentially serious illness that occurs 

naturally in the U.S. It is caused by the bacterium 

Francisella tularensis found in animals (especially 

rodents, rabbits, and hares). The bacteria that cause 

tularemia occur widely in nature and could potentially 

be isolated and grown in quantity in a laboratory, 

although manufacturing an effective aerosol weapon 

would require considerable sophistication.

In October 2021, FDA qualified a National 

Institutes of Health (NIH) National Institute of Allergy 

and Infectious Diseases (NIAID) cynomolgus macaque 

(Macaca fascicularis) animal model of pneumonic 

Bacteria Francisella tularensis, 3D illustration

F. tularensis under the Animal Model Qualification 

Program (AMQP). The qualification of this model may 

help speed the development and approval of drugs and 

biological products for the treatment of pneumonic 

tularemia. 

The AMQP is a Drug Development Tool 

tularemia caused by the inhalation of aerosolized 

Qualification Program specifically established to 

address the need for publicly available, productindependent animal models intended to support the 

efficacy testing of multiple investigational drugs or 

biological products under the regulations commonly 

known as the Animal Rule. The AMQP provides a 

framework for early engagement and scientific 

collaboration with FDA to facilitate animal model 

development. 
19

ACTION TEAMS

Under the MCMi Program, FDA established multidisciplinary Public Health and Security Action Teams (Action 

Teams) as necessary to advance MCMs for priority 

threats by working with internal and external entities—

as appropriate—to identify and catalyze the resolution 

of regulatory and scientific challenges to MCM development. The following information summarizes activities 

of the Action Teams that were active in FY 2022.

Microbial Sequencing and Multiplex 

In Vitro Diagnostics Action Team

This Action Team continued its work to support 

sequence-based diagnostic device development. Such 

diagnostics may include multiplex diagnostic devices, 

which test for multiple pathogens simultaneously from 

a single clinical specimen, providing valuable information when responding to a public health emergency.

Key activities during FY 2022 included:

• Continuing collaboration with the National 

Center for Biotechnology Information (NCBI), the 

Lawrence Livermore National Laboratory (LLNL), 

and the Institute for Genome Sciences at the 

University of Maryland to establish quality criteria 

for microbial reference databases that will be critical to developers seeking to validate their candidate 

next-generation sequencing (NGS)-based IVD tests.

• Continuing to facilitate the population of a publicly 

available database for reference-grade microbial 

genomic sequences, FDA-ARGOS. In FY 2022, 

FDA continued to seek SARS-CoV-2 reference-grade sequence data for the FDAARGOS database and develop a software pipeline 

to expand the current ARGOS database.

• Continuing collaboration with the National Institute 

of Standards and Technology (NIST) to develop 

mixed microbial reference materials that will be critical to developers seeking to validate their candidate 

NGS-based IVD tests, and produce both microbial 

and human reference genome samples and materials 

to support the development and validation of NGS 

instrumentation/software platforms for sequencing 

microorganism and human nucleic acids.

• Sustaining an interactive collaboration with 

DoD on the development of its Next-Generation 

Diagnostic System (NGDS Increment II).

• Collaborating with DoD to assess the impact of 

viral mutations on PCR performance.

FDA/DoD Enhanced Engagement Action Team 

This Action Team continued its efforts to facilitate the 

development and regulatory assessment of MCMs and 

related technologies primarily to support U.S. military 

personnel and trauma victims. 

Key FY 2022 activities included:

• Working with DoD partners to support COVID-19 

response efforts, including:

◦ The use of EUA diagnostic tests.

◦ With the U.S. Army Medical Research and 

Development Command’s (USAMRDC) Telemedicine and Advanced Technology Research Center 

(TATRC), supporting the rapid development, 

deployment, and testing of the National 

Emergency Telecritical Care Network (NETCCN). 

• Continuing a joint program established 

under Public Law 115-92 to prioritize the efficient 

development of safe and effective medical products 

intended for deployed American military 

personnel, including: 
20

◦ Meeting with DoD offices, commands, and 

programs to discuss regulatory and scientific 

issues related to developing and providing 

access to medical products for the warfighter;

◦ Expediting the review of priority DoD medical 

products in a manner similar to products under 

the breakthrough therapy designation 

program; and 

◦ Providing ongoing technical advice to DoD to aid 

in the rapid development and manufacturing of 

medical products for use by the military.14

• Continuing a formal fellowship program between 

FDA and DoD to support the training of DoD 

scientific and medical personnel in medical product development and FDA’s regulatory processes. 

Two DoD laboratory experts are currently being 

cross-trained in regulatory review at FDA.

• Facilitating the approval of an improved 

midazolam autoinjector and a naloxone 

autoinjector to protect the warfighter against 

chemical warfare exposure.

• Providing expert feedback on regulatory 

considerations for novel CBRN prophylactic 

approaches identified by the Defense Advanced 

Research Projects Agency (DARPA).

• Engaging with DoD’s JPEO-CBRND to address 

ongoing nonclinical testing supply chain challenges.

• Strengthening MCM CBRN research and development through partnership and engagement with 

Australia, Canada, and the United Kingdom to 

support defense and public health.

Acute Radiation Syndrome (ARS) Action Team 

This Action Team continued its efforts to clarify the 

regulatory requirements for development of MCMs to 

combat radiological/nuclear (rad/nuc) threats, which 

include products for improving survival and mitigating 

or treating injuries from rad/nuc events, and products for 

determining subject exposures in a nuclear detonation. 

Key activities during FY 2022 included:

• Continuing coordinating FDA rad/nuc preparedness 

activities and working with scientific and regulatory 

experts across the FDA to enhance development of 

MCMs for cutaneous radiation injury.

• Continuing to interact with USG partners via 

Biodosimetry Working Group meetings to engage 

interagency stakeholders in discussion on regulatory challenges for radiation biodosimetry devices, 

updating the pre-EUA template for molecular 

biodosimetry, establishing a draft pre-EUA 

template for cytogenetic biodosimetry, and 

supporting biodosimetry review group activities, 

including review of five pre-submissions relating 

to three radiation biodosimetry devices.

• Continuing to facilitate cross-agency rad/nuc interaction on MCM development for gastrointestinal acute 

radiation syndrome (GI-ARS) that includes the FDA 

Center for Drug Evaluation and Research (CDER) 

co-sponsoring with NIAID and BARDA a workshop to 

discuss development of GI-ARS animal models. 

• Working with USG partners to address the challenges and gaps in the development of pediatric 

rad/nuc MCMs.

• Continuing providing regulatory input on the draft 

Global Health Security Initiative (GHSI) Nuclear 

Detonation Playbook, and the Administration 

for Strategic Preparedness and Response (ASPR) 

Radiation Emergency Medical Management 

(REMM) guidance document for myeloid cytokine 

treatment of acute exposure to myelosuppressive 

doses of radiation.

• Providing FDA reviewers with training on national 

preparedness for medical response to a rad/nuc 

emergency and ASPR rad/nuc response strategies.

14 In FY 2019, FDA and DoD signed a Memorandum of Understanding (MOU) setting forth the framework for the ongoing 

partnership and the creation of a robust program that can better serve the health care needs of American military personnel. 

This MOU builds upon the work of both agencies to foster and prioritize the efficient development of safe and effective medical 

products intended to save the lives of American service members.
21

REGULATORY ADVICE 

AND GUIDANCE

During FY 2022, FDA continued to provide regulatory 

advice and scientific guidance to sponsors and 

applicants of MCMs and our federal partners funding 

MCM development, to help foster the development and 

availability of various MCMs. FDA provides regulatory 

advice and guidance through a variety of mechanisms 

including direct engagement with sponsors and applicants, issuing guidance documents, and holding 

Advisory Committee meetings and public workshops. 

COVID-19

FDA remains committed to providing timely recommendations, regulatory information, scientific advice, 

guidance, and technical assistance necessary to support 

rapid COVID-19 response efforts. In addition to continually communicating with stakeholders in frequent web 

updates, emails, and responses to individual inquiries, 

in FY 2020 - FY 2022, not including revisions, FDA 

issued 84 new guidance documents (63 in FY 2020, 

16 in FY 2021, and five in FY 2022) to provide policies, 

transparency, and regulatory flexibility, as appropriate, 

to address the vital medical products and public health 

issues facing the U.S. during this pandemic. The agency 

continues to update these guidances as relevant needs 

and circumstances have evolved, and has withdrawn 

several COVID-19-related guidances after determining 

that the policies no longer represented the agency’s 

current thinking. The COVID-19 guidances FDA has 

issued address diagnostics, PPE, ventilators, other medical devices, conduct of clinical trials of medical products, 

blood supply, development of drugs and biological products to treat or prevent COVID-19, and other topics. FDA 

also issued guidance documents that help foster MCM 

development and availability and sought input from a 

variety of stakeholders through webinars, workshops, 

town hall meetings, and other engagements. 

Engaging with product sponsors

FDA medical product review centers engage with MCM 

sponsors and applicants throughout the product life 

cycle. For example, FDA reviews IND applications 

and Investigational Device Exemptions (IDEs) and 

responds to questions from sponsors, applicants, and 

federal agencies supporting product development. 

FDA medical product review centers have extensive 

interactions to discuss testing, data requirements, 

and nonclinical development plans to move candidate 

MCMs into clinical development and assess progress 

as these specialized product candidates move through 

clinical development toward a marketing application. 

FDA also continues to engage with sponsors and applicants to address any issues that arise during regulatory 

review as well as during the post-marketing phase for 

these MCMs.

FDA medical product review centers 

engage with MCM sponsors and applicants 

throughout the product life cycle.

FDA has established policies and procedures for 

conducting formal meetings with product sponsors 

or applicants. For detailed information on meetings 

about product development, please see the Search 

for FDA Guidance Documents web page, and 

enter the desired search criteria, e.g., the term “meetings.” Formal meetings are held—as needed—at the 

request of a product sponsor or applicant, and requests 

for meetings are granted unless there is a substantive reason for denying the request (e.g., the product 

for which the meeting is requested is not sufficiently 
22

developed to warrant the type of meeting sought). 

When FDA denies a request for a meeting, the sponsor 

or applicant is provided feedback on steps required 

to warrant a meeting. Formal meetings may also be 

rescheduled or canceled based on criteria described 

in FDA guidance.

Types and numbers of drug and 

biologic product meetings 

Under the Prescription Drug User Fee Act (PDUFA), 

the Center for Biologics Evaluation and Research 

(CBER) and CDER categorize formal meetings with 

product sponsors and applicants of NDAs and BLAs 

as Type A, B, and C. Type A meetings are meetings 

to help an otherwise stalled product development 

program proceed (such as a dispute resolution 

meeting, a meeting to discuss a clinical hold,15 and a 

Special Protocol Assessment (SPA) meeting).

Type B meetings are meetings held at pivotal points 

during product development to help products move 

into and through clinical development to marketing 

application (e.g., pre-IND application meetings, certain 

end-of-phase 1 meetings, end-of-phase 2/pre-phase 3 

meetings, and pre-NDA/BLA). Type B meetings also 

include pre-EUA meetings, Risk Evaluation and 

Mitigation Strategies (REMS) meetings, and certain 

meetings for breakthrough therapy-designated 

products, as explained in the revised draft guidance 

Formal Meetings Between the FDA and Sponsors or 

Applicants of PDUFA Products.

Type C meetings are any meetings under PDFUA 

regarding the development and review of a product 

other than a Type A or Type B meeting, and can address 

a range of issues (e.g., discussions related to data 

requirements, scientific issues related to product 

development and manufacturing, post-marketing 

commitments or requirements, etc.). Meetings that 

are not categorized as Type A, B, or C are non-PDUFA 

meetings such as meetings on a sponsor’s compliance 

status or follow-up on post-marketing commitments.

To provide general considerations to assist sponsors in preparing pre-IND meeting requests for 

COVID-19 related drugs for the duration of the 

COVID-19 public health emergency, in May 2020, 

FDA issued the guidance COVID-19 Public 

Health Emergency: General Considerations 

for Pre-IND Meeting Requests for COVID-19

Related Drugs and Biological Products. As 

described in further detail in this guidance, FDA 

recommends that sponsors initiate all drug development interactions for COVID-19 related drugs through 

Pre-IND meeting requests. 

In FY 2022, CBER held 28 formal meetings with 

MCM sponsors or applicants and 94 other (nonPDUFA) meetings, and CDER held 13 formal meetings 

(Table 3) and 96 other (non-PDUFA) meetings.

Types and numbers of medical device meetings

CDRH categorizes its meetings with product sponsors 

as Pre-Submission (Pre-sub) and 510(k)/PMA Submission meetings. Pre-sub meetings are designed for 

FDA staff to provide feedback in response to specific 

questions related to product development, including 

planned nonclinical evaluations, proposed clinical 

study protocols, regulatory pathways, or data analysis 

recommendations prior to making a submission. 

CDRH received 109 Pre-subs and nine Submission 

issue meeting requests (related to marketing submissions) for MCM medical devices in FY 2022. FDA 

provided extensive written feedback on the Pre-subs, 

and many of these sponsors elected to cancel meetings 

after receiving this written feedback, as they did not 

see the need for the originally requested meeting. If the 

sponsor wanted to further discuss the written Pre-sub 

Table 3: FY 2022 formal meetings between CBER/

CDER and MCM sponsors or applicants 

Meeting Type CBER CDER

Type A 2 1

Type B 23 2

Type C 3 10

Total 28 13

15 A clinical hold is an order issued by FDA to a product sponsor to delay a proposed clinical investigation or to suspend an 

ongoing investigation. See 21 Code of Federal Regulations (CFR) 312.42. 
23

feedback, a Pre-sub meeting was held. Submission issue 

meetings are sometimes held to discuss deficiencies 

identified during premarket review of device marketing 

applications and to provide clarification of FDA’s questions or to discuss an approach to address any complex 

issues identified. In FY 2022, CDRH provided written 

feedback for 72 MCM Pre-sub or Submission applications and held 37 Pre-sub and 9 Submission issue meetings with MCM sponsors or applicants (Table 4).

In addition to the marketing applications discussed 

in the previous paragraph, CDRH had significant 

interactions with MCM sponsors during the pre-EUA 

and EUA Interactive Review process. The Interactive Review process was developed to facilitate the 

efficient and timely review and evaluation of pre-EUA 

and EUA submissions through increased interaction 

between FDA and sponsors, including the exchange 

of scientific and regulatory information.16 In FY 2022, 

CDRH reviewed and provided written feedback on 

numerous pre-EUAs and EUA submissions, with many 

submissions involving multiple rounds of written 

feedback provided during interactive review, and held 

pre-EUA and EUA meetings to facilitate validation and 

development (telecons). 

Other regulatory advice and guidance

In addition, eligible MCM sponsors or applicants can 

request a Regulatory Management Plan (RMP), 

setting forth a process whereby the terms for interactions between FDA and the product sponsor or 

applicant can be delineated. FDA did not receive any 

written MCM-related RMP requests in FY 2022. 

FDA also conducted enhanced inspection and 

compliance activities to support early identification of 

any problems that might impede MCM product development. FDA provided technical advice to minimize risk 

during MCM product manufacturing, including preapproval inspections or site visits to ensure that manufacturing establishments are capable of adequately 

manufacturing MCM products, and that submitted 

application data are accurate. 

In addition to its direct work with MCM sponsors 

and applicants, FDA also issues guidance documents 

that help foster MCM development and availability.17

Guidance documents issued during FY 2022 directly 

related or applicable to MCM policies or regulatory 

issues are listed in Appendix 3. 

FDA also holds Advisory Committee meetings 

and public workshops to obtain independent input 

and expert advice on scientific, technical, and policy 

matters to facilitate MCM development. Key meetings 

and public workshops held during FY 2022 are listed 

in Appendix 4. In addition to these FDA-hosted 

meetings, FDA experts continued to participate in 

and present at a wide variety of other meetings, 

workshops, and conferences.

Table 4: FY 2022 meetings between CDRH and 

MCM sponsors or applicants 

Meeting Type CDRH

Pre-Submission 37

Submission issue meetings 9

Total 46

What are guidance documents?

Guidance documents are documents prepared 

for FDA staff, applicants/sponsors, industry, and 

the public that describe FDA’s non-binding 

interpretations or recommendations.

16 For more information on the Interactive Review Process see Types of Communication During the Review of Medical Device 

Submissions - Guidance for Industry and FDA Staff.

17 Guidance documents include, but are not limited to, documents that relate to the design, production, labeling, promotion, 

manufacturing, and testing of regulated products; the processing, content, and evaluation or approval of submissions; and 

inspection and enforcement policies. (21 C.F.R. § 10.115(b))
24

COLLABORATION AND 

COMMUNICATION

During FY 2022, FDA continued to collaborate

extensively with other USG partners to foster the 

development and availability of MCMs. FDA provided 

subject matter expertise and technical assistance to 

approximately 71 standing interagency and HHS/

PHEMCE- and DoD-specific committees and working 

groups that develop MCM requirements, plans, priorities, and policies and conduct program oversight and 

integration. These standing committees and working 

groups met on a weekly, monthly, bimonthly, quarterly, semi-annually, or as-needed basis depending on 

the requirements of the issues at hand. These committees and working groups addressed a range of topics 

across the full spectrum of activities associated with 

MCMs including threat assessment, requirements 

setting, product development, procurement, stockpiling, utilization, and monitoring and assessment of 

MCMs after they have been dispensed or administered. 

In addition, FDA supported USG partners by providing subject matter expertise for various MCM-related 

proposal reviews. FDA also continues to support implementation of the National Biodefense Strategy. 

FDA continued to work with state, local, tribal, 

and territorial (SLTT) public health authorities and 

responders and public health non-governmental 

organizations (NGOs) to support MCM preparedness 

and response capabilities at the state and local levels, 

including responding to numerous legal and regulatory 

inquiries concerning EUA and other emergency use 

authorities, and MCM stockpiling, expiry dating, distribution, and dispensing. FDA continues to participate 

in multiple national-level workshops and meetings on 

public health and legal preparedness. For example, FDA 

continues to sustain support for and participate in:

• The annual Public Health Preparedness 

Summit convened by the National Association of 

County and City Health Officials (NACCHO).

• The National Academies of Sciences, 

Engineering, and Medicine, Health and Medicine 

Division (NASEM-HMD) Forum on Medical 

and Public Health Preparedness for 

Disasters and Emergencies, to provide 

national leadership in coordinating ongoing efforts 

among members from federal, state, and local 

BOX 3: FEATURED COLLABORATIONS

CDC and public health labs: 

Enhancing testing surge capacity

In May 2022, FDA, CDC, 

and several private 

stakeholders signed a new 

Memorandum of Understanding (MOU) to collaborate on enhancing laboratory testing surge capacity 

outside of CDC and public 

health laboratories before 

and during public health 

emergencies. Partnerships and engagement 

between the public and private sector are crucial 

to supporting a significant increase in demand for 

diagnostic testing during a public health emergency and to respond to emerging public health 

threats before reaching the level of a pandemic.

NIST: Supporting supply chain resilience

In 2021, FDA created a 

new collaboration with 

NIST through an MOU

intended to increase U.S. 

medical supply chain 

resilience and advanced 

domestic manufacturing of 

drugs, biological products and medical devices 

through adoption of 21st

century manufacturing technologies. These include 

smart technologies, such as artificial intelligence 

(AI) and machine learning, and emerging manufacturing processes. Under this MOU, in September 

2022, FDA and NIST launched a new project to 

develop new methods to standardize description 

of the temperature sensitivity and stability of mAbs 

and other large molecules used for vaccines and 

therapeutics. This work could help reduce the 

burden on cold storage supply chains and help 

facilitate the distribution of mAbs and other 

biomolecules during public health emergencies.

More MCMi Collaborations
25

government; business; and professional associations to develop sustainable partnerships between 

the public and private sector so that communities 

are adequately prepared for natural or humanmade catastrophic events.

• The Tri-Agency Task Force for Emergency 

Diagnostics (TTFED), launched in February 2019, 

to help leverage the expertise of each agency to 

better coordinate implementation of diagnostic 

tests in clinical and public health laboratories 

during public health emergencies.

FDA also participates in a variety of research and 

other activities to support One Health, a collaborative, multisectoral, and transdisciplinary approach—

working at the local, regional, national, and global 

levels—with the goal of achieving optimal health 

outcomes recognizing the interconnection between 

people, animals, plants, and their shared environment. 

In FY 2022, FDA’s agency-wide One Health Steering 

Committee reviewed and provided feedback to federal 

interagency strategic frameworks including:

• U.S. Department of Agriculture (USDA) Animal 

and Plant Health Inspection Service (APHIS) 

American Rescue Plan Surveillance Program 

Strategic Framework – To facilitate One Health 

interagency interactions and needed collaboration to enhance SARS-CoV-2 and other emerging 

disease surveillance in animals to prevent or limit 

zoonotic disease outbreaks.

• CDC National One Health Framework

To address zoonotic diseases in the U.S., including 

facilitating collaboration across federal agencies.

International collaborations

In addition to working with federal and SLTT 

governments and NGOs, FDA continued to work with 

international partners such as WHO to foster the 

development and availability of MCMs.

Agreements between FDA and its international 

counterparts established in previous years have 

continued to support information-sharing and collaboration and have better prepared the international 

regulatory community to respond to COVID-19 and 

FDA is an active participant in numerous 

MCM-related international collaborations

including:

• WHO’s R&D Blueprint – A global strategy 

and preparedness plan intended to allow the 

rapid activation of research and development 

activities during epidemics; its aim is to fast-track 

the availability of effective tests, vaccines, and 

medicines that can be used to save lives and 

avert large-scale crisis

• Coalition for Epidemic Preparedness 

Innovations (CEPI) - An innovative partnership 

between public, private, philanthropic, and civil 

organizations that aims to stop future epidemics 

by developing new vaccines

• Global Research Collaboration for Infectious 

Diseases Preparedness (GloPID-R)

The only network of major research funding 

organizations working on a global scale; 

together, these organizations strive to facilitate 

an effective research response within 48 hours 

of an infectious disease outbreak

• International Coalition of Medicines 

Regulatory Authorities (ICMRA)

Comprised of medicines regulators worldwide 

who have committed to enhanced cooperation 

with the WHO and among regulatory agencies 

to encourage submission of regulatory dossiers 

and evaluation of the submitted information on 

potential new medicines to address emerging 

public health threats

• Foundation for Innovative New Diagnostics 

(FIND) - A WHO Collaborating Centre for 

Laboratory Strengthening and Diagnostic 

Technology Evaluation, FIND is a global nonprofit 

organization driving innovation in the development and delivery of diagnostics to combat major 

diseases affecting the world’s poorest populations
26

future public health emergencies. Examples of FDA’s 

key international MCM collaborations include:

• Working with HHS to help establish legal frameworks and tools to facilitate sharing MCMs during 

an international public health emergency.

• Supporting and participating in the U.S. government’s Global Health Security Agenda (GHSA) 

and strategy, as well as other HHS-led efforts 

related to global MCM legal and policy 

frameworks, including through Joint External 

Evaluation (JEE) efforts.

• Implementing CBER-WHO Cooperative 

Agreements to advance global access to safe 

and effective vaccines and build capacities for 

the import, registration, and emergency use of 

pre-qualified MCM vaccines.

• Participating in international consultations to 

advance efforts to conduct research, pharmacovigilance, and product development during public 

health emergencies. 

Enhancing communication

FDA continued extensive agency-wide efforts to 

communicate openly and often about its response 

to the COVID-19 pandemic, including issuing well 

over 100 press releases, hundreds of email updates, 

and numerous other communications, including web 

updates, videos, and social media in FY 2022, to help 

promote confidence in the public health response. 

Intensive stakeholder outreach also continued, 

including town hall meetings, webinars, workshops, 

email alerts, and individual outreach.

In addition to extensive COVID-19-related communication, FDA continued ongoing work to enhance 

communication related to MCM preparedness and 

response through a variety of outreach activities 

(e.g., MCMi email newsletter, social media, and 

various presentations).

MEDICAL COUNTERMEASURE 

REGULATORY SCIENCE

The MCMi Regulatory Science Program 

helps translate cutting-edge technologies 

into innovative, safe, and effective MCMs.

In FY 2022, FDA continued to implement the MCMi 

Regulatory Science Program through intramural and extramural collaborative research, as well as 

through partnerships with U.S. government agencies, 

academia, and industry. The goal of the MCMi Regulatory Science Program is to develop tools, standards, 

and approaches to assess MCM safety, efficacy, quality, 

and performance, and to help translate cutting-edge 

science and technology into innovative, safe, and 

effective MCMs, including for specific populations.18

Challenges inherent in reviewing MCMs

MCMs often present unique and complex challenges 

with respect to developing the data necessary to 

support public health, clinical, and regulatory decision-making. For example, many of the high-priority 

threats for which MCMs are being developed do not 

occur naturally to an extent that would support the 

conduct of field efficacy studies in humans, and it is 

not ethical to conduct human challenge studies with 

threat agents that would pose unacceptable risks to 

study volunteers. In these situations, efficacy data from 

adequate and well-controlled animal studies may be 

used if the results are reasonably likely to predict 

clinical benefit in humans.

The challenges are even more complex when it 

comes to developing MCMs for use in specific populations, such as children or pregnant individuals. For 

example, ethical evaluation of the participation of 

children in clinical trials depends on both the level of 

risk and the prospect of direct benefit to the partici18 Many projects described in this section are preliminary and/or exploratory in nature. Listing a project does not imply any 

determination with regard to utility in public health, clinical, or regulatory decision-making.
27

pant. Thus, in some circumstances it may not be ethical 

to conduct certain types of clinical trials in the pediatric 

population to obtain data that can be used for approving pediatric indications for MCMs—such as safety or 

dosing information—and FDA may rely on the extrapolation of efficacy data from adult populations, along 

with information and experience the agency has with 

the use of a particular class of product (e.g., monoclonal antibodies for use in the pediatric population) to 

the extent permitted by law. For example, pharmacokinetic modeling was the basis for pediatric labeling of 

the monoclonal antibody raxibacumab, approved in 

2012 to treat inhalational anthrax, in combination with 

appropriate antibacterial drugs, and for prophylaxis of 

inhalational anthrax when alternative therapies are not 

available or are not appropriate. 

MCM-related regulatory science research 

tools funded (or partially funded) by FDA 

are available at no charge to help MCM 

researchers advance their products, 

and help FDA reviewers evaluate MCM 

products for approval.

MCM research portfolio

FDA has established a broad and robust intra- and 

extramural research portfolio under the MCMi Regulatory Science Program to meet its goals in these priority 

research areas. Intramural FDA MCM regulatory 

science is funded through a competitive challenge 

grant process. Extramural MCM regulatory science 

is funded primarily through a Broad Agency 

Announcement (BAA), “FDA Broad Agency 

Announcement for the Advanced Research and 

Development of Regulatory Science.”

To ensure that the MCMi Regulatory Science 

Program is appropriately targeted and coordinated with 

USG MCM priorities, FDA coordinates with interagency partners including representatives from NIH, 

CDC, BARDA, and DoD to evaluate MCMi Regulatory 

Science Program research proposals for scientific/

technical merit, feasibility, and for alignment with 

PHEMCE priorities. FDA continually engages with USG 

stakeholders to maintain an MCMi Regulatory Science 

Program that actively addresses current regulatory 

science gaps.

In a 2022 update to the Focus Areas of Regulatory 

Science (FARS) report, FDA identified public health 

preparedness and response as a key area needing 

continued, targeted investment in regulatory science 

research to facilitate development of innovative products, provide data and methods to inform regulatory 

decision-making, and improve guidance to sponsors. 

Supporting COVID-19 response 

with regulatory science

Beginning in 2020, and continuing into FY 2022, FDA 

has initiated a number of regulatory science projects 

to support development and evaluation of MCMs to 

prevent, treat, or diagnose COVID-19. Some notable 

activities since these efforts began include:

• Developing a reference panel to aid in the evaluation of diagnostic tests for SARS-CoV-2. The reference panel provided test developers with well-characterized reagents to compare the sensitivity and 

specificity of different molecular diagnostic tests. 

Work is ongoing to keep reference materials up to 

date with respect to circulating variants.

• Participating in evaluation of antibody and RNA 

reference materials developed by the National 

Institute of Biological Standards and Control under 

the auspices of the WHO, as candidate international 

standards for assays used to detect SARS-CoV-2.

• Supporting development of animal models that 

might help to evaluate COVID-19 vaccines and 

therapeutics.
28

• Supporting development of in vitro models 

(including MPS) that might be relevant to 

exploration of infectious processes and potential 

countermeasure activity.

• Developing assays that might be useful in 

evaluation of vaccine and therapeutic responses.

• Characterizing coronavirus variants and 

host-pathogen responses.

• Describing responses (e.g., MCM activity and 

pathogenicity) in nonclinical and clinical samples 

of SARS-CoV-2, including variants of concern.

• Exploring a predictive model in pediatric patients 

to forecast if a patient is likely to have long-term 

health effects after COVID-19.

• Establishing next-generation sequencing 

quality tools to assess SARS-CoV-2 and SARSCoV-2 variants of concern sequences, adding them 

to the FDA-ARGOS database to ultimately publish 

regulatory grade sequence information.

• Using systems biology and machine learning 

approaches to enable comparison between 

in vitro and in vivo models and clinical data of 

host-pathogen responses, enabling enhanced and 

host-directed MCM screening methods, and laying 

the groundwork for extending this approach to 

emerging pathogens.

• Developing computational models for PPE 

integrity to support supply chain resiliency.

Regulatory science to support public health 

emergency preparedness and response

In FY 2022, the MCMi Regulatory Science Program 

awarded a new contract to develop a predictive model 

in pediatric patients to forecast if a patient is likely 

to have long-term health effects after COVID-19. 

The program also revised three previously awarded 

extramural research contracts to expand efforts 

supporting COVID-19 response, including enhancing 

FDA-ARGOS COVID-19 data, furthering COVID-19 

organ-on-chip development, and supporting data 

visualization for immune responses in vaccinated, 

treated, and infected patients. 

Additionally, FDA expanded an existing research 

project for filovirus MCM development by collecting 

biological samples from health care workers responding 

to a 2022 Ebola outbreak in DRC. 

FDA intramural research supported by MCMi in 

FY 2022 includes 12 new research projects performed 

by FDA scientists, including development of assays 

and models (e.g., nonclinical models including 

computational and in vitro models) to facilitate 

development and evaluation of MCMs for nerve agents 

and infectious diseases including pandemic influenza, 

COVID-19, Marburg, and Zika.

FDA also continued work to build and maintain a national capability to monitor and assess 

MCMs after they are dispensed or administered in 

response to a CBRN threat or emerging infectious 

disease. In FY 2022, FDA continued collaboration 

with Harvard Pilgrim Health Care to explore how the 

Sentinel System—an active surveillance system that 

uses routine querying tools and pre-existing electronic 

BOX 4: MCM regulatory science research areas

Priority research areas sustained under the 

MCMi Regulatory Science Program to support 

preparedness for high-priority threats include:

Identifying, developing, and qualifying drug development 

tools, such as animal models and immune biomarkers to 

assess safety and efficacy of MCMs

Developing and evaluating novel assays and models 

to study emerging infectious diseases

Developing and qualifying in silico predictive models 

(e.g., computational models) and in vitro assays 

(e.g., microphysiological systems [MPS]) to complement 

the use of in vivo animal models to assess safety and 

efficacy of MCMs

Developing tools to support validation of next-generation 

in vitro diagnostic platforms

Developing reference materials related to CBRN threat 

agents and emerging infectious diseases to facilitate 

development of MCMs

Assessing the performance of emergency medical 

equipment including personal protective equipment (PPE)

Enhancing emergency preparedness and response 

capabilities, and tracking and evaluating the safety and 

clinical benefit of MCMs used during public health 

emergencies

Advancing broadly applicable, commercially ready tools, 

technologies, and platforms that can improve the manufacturing efficiency, consistency, and quality of MCMs
29

health care data from multiple sources to monitor the 

safety of regulated medical products—may inform 

study protocols for MCM safety and effectiveness and 

to provide a valuable baseline for comparison during a 

public health emergency. The FDA Sentinel System is 

conducting a number of activities in support of the 

COVID-19 response. Additionally, FDA is participating in the Systemic Harmonization and Interoperability Enhancement for Laboratory Data (SHIELD)

collaborative, in partnership with the COVID-19 

Diagnostics Evidence Accelerator, to harmonize 

COVID-19 test data referenced in the HHS COVID-19 

laboratory data reporting requirements,19 to support 

evaluation of real-world performance of SARS-CoV-2 

diagnostic tests and antibody tests.

FY 2022 MCMi Regulatory Science Program activities 

are included on the following page in Table 5.

BOX 5: FEATURED MCMI-FUNDED 

EXTRAMURAL PROJECTS

Understanding long COVID in children

In a project begun in 

June 2022, FDA is working with Children’s Hospital Los Angeles (CHLA) on 

pediatric disease modeling for long COVID-19 

(also called post-acute 

COVID syndrome [PACS], 

or post-acute sequelae of 

COVID-19 [PASC]).

This project leverages the NIH RECOVER initiative 

to study PASC in children, including researching 

pediatric cohorts to identify a COVID-19-specific 

inflammatory and tissue damage disease signature, 

and determine how obesity may affect the inflammatory response. The project will also identify 

potential biomarkers that correlate to tissue injury 

during the disease course and test therapeutics 

against these targets to discern if modulating target 

activity improves disease outcomes.

Strengthening coronavirus models with 

systems biology and machine learning

Australia’s national science 

agency CSIRO 

(Commonwealth Scientific 

and Industrial Research 

Organisation) and global 

partners will use systems 

biology and machine 

learning approaches

to enhance the understanding of nonclinical 

model responses to SARS-CoV-2.

They will perform genomic and bioinformatic 

analysis of the SARS-CoV-2 virus and its key 

variants, as well as multi-omics analyses (including 

transcriptomics, metabolomics, lipidomics, and 

proteomics) on different types of samples collected from a range of nonclinical in vitro (organoid/

tissue) models and in vivo models, as well as from 

clinical studies on COVID-19 and long COVID-19.

SHIELD collaborative

The SHIELD collaborative is a multi-agency/stakeholder network consisting of FDA, CDC, NIH, 

HHS Office of the National Coordinator for Health 

Information Technology (ONC), Centers for Medicare and Medicaid Services (CMS), U.S. Department of Veterans Affairs (VA), IVD manufacturers, 

electronic health record vendors, laboratories, 

College of American Pathologists, standards 

developers, Pew Charitable Trusts, National 

Evaluation System for health Technology (NEST), 

and academia.

COVID-19 Evidence Accelerator

The COVID-19 Evidence Accelerator is an initiative 

launched by the Reagan-Udall Foundation for the 

FDA, in collaboration with Friends of Cancer 

Research, to provide a unique venue for major data 

organizations, government and academic 

researchers, and health systems to gather and 

design quick-turn-around queries and share their 

results The project includes a Diagnostics Evidence

Accelerator and a Therapeutics Evidence Accelerator.

19 COVID-19 Pandemic Response, Laboratory Data Reporting: CARES Act Section 18115
30

Table 5: MCMi Regulatory Science Program activities in FY 2022

CBRN

Developing models of radiation damage in lung, gut, and bone marrow organs-on-chips and then using these models to 

test candidate MCMs to treat such damage. In FY 2022, the project continued to characterize the interplay between human 

bone marrow organs-on-chips and intestine organs-on-chips that include a complex human gut microbiome in response to 

radiation exposure.

Developing novel reagents to support MCMs for organophosphate nerve agents and biological toxins (e.g., botulinum toxin)

Working with the Reagan-Udall Foundation to hold stakeholder meetings on EUA processes and the use of MCM master 

files to advance use of platform technologies to support development of MCMs

Emerging threats (e.g., SARS-CoV-2, Ebola, Marburg, and mpox)

Creating disease models for pediatric long COVID, in a new project begun in June 2022

Expanding a database of reference-grade nucleic acid sequences for emerging threats, to include viruses such as Ebola 

and Zika, and antimicrobial-resistant pathogens. For example, in April 2020, SARS-CoV-2 reference-grade sequence 

data was added to the FDA-ARGOS database.

Expanding a project to develop quality metric tools for next-generation sequencing databases to support SARS-CoV-2 

and influenza diagnostics. This project will also complement the MCMi-supported FDA-ARGOS database.

Continuing to support improvement of small and large animal models for emerging threats (e.g., SARS-CoV-2, Ebola, 

Marburg, and pandemic influenza)

Conducting survivor studies to better understand Ebola’s after-effects, to help find new treatments

Applying advanced transcriptomic analysis (the study of all messenger RNA from the genes of an organism) to compare

host responses to Ebola virus disease in humans and in animals, to help identify biomarkers of Ebola, and expected 

disease outcomes

Developing a unique biobank of clinical Ebola samples from over 2,500 participants, including investigational Ebola 

vaccinees, Ebola survivors, and Marburg survivors, to characterize the durability and correlates of vaccine-induced and 

natural immunity to Ebola virus (EVD) and Marburg diseases. In FY 2022, the project was expanded, in collaboration with 

the Defense Threat Reduction Agency (DTRA), to develop a Marburg clinical biobank to support vaccine development to 

study Ebola vaccine durability and collection of blood samples in health care workers responding to a 2022 Ebola outbreak.

Analyzing SARS-CoV-2, SARS-CoV, and Middle East Respiratory Syndrome coronavirus (MERS)-CoV clinical samples, 

collected through global partnerships, to better understand coronavirus evolution and virulence, characterize host-pathogen 

interactions and immunity, and identify biomarkers of disease progression and severity. In FY 2022, this project was expanded 

to study variants of concern, such as the SARS-CoV-2 omicron variant, and potential impacts on MCM efficacy.

Profiling circulating immune signatures of coronavirus infection and completing COVID-19 pathology tissue imaging, 

leveraging novel tools to define the characteristics of tissue viral reservoirs (cell types or areas of the body where the virus 

persists), and learning more how SARS-CoV-2 affects different systems in the body. In FY 2022, this project continued to 

identify biomarkers and immune correlates of protection to further understanding of responses across diverse populations, 

including race, ethnicity, sex, and age to aid the development and evaluation of MCMs for all.

Developing and distributing a reference panel to aid in the evaluation of diagnostic tests for SARS-CoV-2. 

The reference panel provides test developers with well-characterized reagents to compare the sensitivity and specificity 

of different molecular diagnostic tests. In FY 2022, FDA identified an external entity to continue the initial FDA efforts on 

the development and distribution of the FDA SARS-CoV-2 Reference Panel for diagnostic tests, to facilitate long-term 

availability and maintenance of an up-to-date panel with respect to emerging variants.

Participating in evaluation of antibody and RNA reference materials being developed by the National Institute of Biological 

Standards and Control under the auspices of the WHO, as candidate international standards for SARS-CoV-2 assays

Developing tools and assays that support evaluation of COVID-19 MCMs
31

FDA continues to create and support programs 

to advance the development and review of MCMs 

that will be regulated under the Animal Rule, and 

continues agency-wide efforts and external collaborations to advance the use of alternative methods. 

A variety of ongoing collaborations, including MCMi 

regulatory science collaborations, are listed on the 

FDA website at: MCMi Collaborations.

Collaborating with NIH to design a study of SARS-CoV-2 hyperimmune globulin to be conducted by NIAID/NIH

Developing models of emerging infectious diseases (e.g., Ebola, Zika, and SARS-CoV-2) in MPS, including organ chips, for 

potential testing of MCMs

Supporting development of COVID-19 MCMs, including a contract awarded in FY 2021 and continued in FY 2022, to 

strengthen coronavirus models through systems biology, AI, and machine learning

Coordinating with USG partners to ensure that USG-supported candidate MCMs could be independently evaluated for 

activity against SARS-CoV-2 variants of concern

Pandemic influenza

Demonstrating the ability of a universal influenza vaccine candidate to reduce the transmission of influenza virus in 

mice, even though this vaccine does not completely block infection by the virus

Characterizing immune responses against influenza virus proteins to support development of pandemic and universal 

influenza vaccine

Public health emergency preparedness and response

Continuing support of the CDC & FDA Antibiotic Resistance Isolate Bank

Establishing new methods to test PPE to help mitigate shortages during a public health emergency

Collaborating with USG partners and academia to design a comprehensive study to assess at-home COVID-19 antigen 

IVD test performance and evaluate the benefits of serial testing
32

BOX 6: FEATURED REGULATORY SCIENCE COLLABORATIONS

NASA: 3D tissue chips

In March 2022, the National Aeronautics and Space 

Administration (NASA), NIH, BARDA, and FDA

announced the award of eight contracts in a multiagency collaboration to extend longevity of complex in 

vitro (human) models, such as 3D tissue chips and MPS, 

to at least six months. Currently, such chips are viable 

for about one month, limiting researchers’ ability to track 

longer-term effects of treatments on tissues using these 

systems. Results from longer studies could be used to 

better understand disease models, supporting development of and clinical trial design for a variety of MCMs.

DoD: Innovative regulatory tools

FDA has numerous ongoing DoD collaborations to 

develop innovative regulatory tools. Examples include 

work with DARPA and DTRA on biomimetic models, 

and a collaboration with DTRA to develop a Marburg 

clinical biobank.

NIAID/NIH: Microphysiological systems

FDA is collaborating with NIAID to conduct alternative 

methods research, specifically exploring the use of 

human MPS for Ebola and COVID-19, and development 

of nonhuman primate (NHP) models. FDA is collaborating 

on this research with domestic and international academic 

performers at the Wyss Institute for Biologically Inspired 

Engineering at Harvard University, the University 

of Liverpool, and the UK Health Security Agency 

(formerly Public Health England). The COVID-19 MPS 

models, including NHPs, are being used to investigate 

MCM efficacy and to provide a bridge from these models 

to clinical and animal model data.

Credit: NASA

Credit: DoD

Credit: Wyss Institute
33

ADVANCED 

MANUFACTURING

Advanced manufacturing can accelerate therapy 

development, rapidly scale manufacturing capabilities 

for vaccines and other MCMs, as well as shorten supply 

chains to increase manufacturing resilience. The potential public health value of advanced manufacturing is 

even greater in the context of the ongoing COVID-19 

pandemic, which has highlighted the strain on supply 

chains and the need for adaptive manufacturing 

capabilities to accelerate the production of MCMs. 

These innovations in manufacturing technology can 

help support goals of the Cures Act, including by:

• Enabling rapid ramp-up of manufacturing 

capabilities for vaccines and other MCMs to 

respond to emerging threats and other public 

health emergencies, such as pandemic influenza,

• Accelerating the development of therapies for 

orphan diseases by improving the cost-efficiency 

of small-scale manufacturing processes, and

• Enabling manufacturing process and standards 

development for emerging therapies including 

cell and gene therapies.

BOX 7: FEATURED ADVANCED 

MANUFACTURING PROJECT

I-TEAM Hub

FDA has partnered with the HHS ASPR Innovation 

and Industrial Base Expansion (IBx) program to 

create the Innovative Technologies and Advanced 

Manufacturing Hub (I-TEAM Hub). The I-TEAM 

Hub will facilitate:

•Creating a configurable innovation laborator

space to provide FDA reviewers, scientists, and 

investigators hands-on access to innovative 

analytic and manufacturing technologies 

such as digitally enabled manufacturing and 

deployable manufacturing for critical medicines, 

devices, and MCMs.

• Bringing technology and manufacturing 

platforms into FDA and making them available 

FDA-wide for research, evaluation, and use. 

•Supporting technology modernization a

FDA by developing manufacturing quality 

anagement metrics, and by supplying 

real-world data streams to FDA and partner 

information systems.

The I-TEAM Hub includes research and 

collaboration space, remodeled from existing FDA 

facilities, with work beginning in FY 2023. It will 

contain state-of-the-art manufacturing, sensing, 

AI/machine learning, and other cross-cutting 

technology platforms that enable the manufacture 

of medical products. FDA and HHS will continue 

to leverage interactions with industry, academia, 

and other government agencies to identify technologies that may become part of the next generation 

in medical products manufacturing. Some of these 

technologies, that have broad applicability or have 

the potential to transform an industry, may be 

cycled into the Innovation facility. 

The I-TEAM Hub is part of OCET’s Advanced 

Manufacturing Program which supports a 

growing internal knowledge base of lessons 

learned, regulatory science, and cross-industry 

best practices that can be leveraged for FDAregulated products, especially in the areas of 

MCMs and supply chain resilience.

Advanced manufacturing

Advanced manufacturing is a collective term for 

new or innovatively applied medical product 

manufacturing technologies that can improve 

medical product quality, address shortages, and 

speed time-to-market.
34

Advanced manufacturing innovation hub

In September 2022, HHS announced actions the 

department will take following the Executive Order 

on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and 

Secure American Bioeconomy, which launched a 

National Biotechnology and Biomanufacturing Initiative (NBBI). In its implementation of the Executive 

Order, HHS intends to leverage biotechnology and 

biomanufacturing to achieve medical breakthroughs, 

reduce the overall burden of disease, and improve 

health outcomes. HHS will lead the U.S. government 

in strategically advancing biosafety and biosecurity 

innovation as part of a growing bioeconomy, to ensure 

biotechnology research and development and biomanufacturing infrastructure break new ground while 

reducing risk. This includes supporting development of 

an advanced manufacturing innovation hub in 

FDA’s Office of Counterterrorism and Emerging Threats 

(OCET), in the Office of the Chief Scientist (OCS), to 

facilitate creation of regulatory science benchmarks and 

strategies for platform technologies and to drive collaborations that affect multiple product areas (e.g., smart 

manufacturing, closed loop process controls).

Continued collaborations

Collaborations begun in previous years also continue. 

An MOU between FDA and NIST signed in FY 2021 

is promoting use of advanced manufacturing methods 

including real-time analytics and process control to 

support supply chain resilience and domestic manufacturing. In September 2022, FDA and NIST launched a 

new project to develop new methods to standardize 

description of the temperature sensitivity and stability 

of mAbs and other large molecules used for vaccines 

and therapeutics. When new mAbs and other large 

biomolecules for drugs and vaccines are developed, 

they often must be stored in very cold temperatures 

to ensure their quality and efficacy. This puts a large 

burden on the supply chain to maintain these 

freezing temperatures. Testing to reduce cold storage 

requirements takes time, and there is often not enough 

information about these biomolecules to predict their 

temperature sensitivity. This effort will help gain some 

of that information to understand molecule stability 

at different temperatures, simplifying test design and 

reducing testing to more quickly reduce the burden 

on cold storage supply chains and help facilitate the 

distribution of mAbs and other biomolecules during 

public health emergencies. 

BOX 8: FEATURED ADVANCED 

MANUFACTURING PROJECT

Smart Design and Manufacturing Pilot

In FY 2021 OCET, in collaboration with CDRH, 

acquired a smart manufacturing demonstration 

system to use as a shared resource FDA-wide. 

The system is intended to increase FDA capabilities to develop metrics, inspectional guidelines, 

guidance documents, and policy for supply chain 

resilience and will help facilitate increased 

adoption of innovative technologies. Implementation activities in FY 2022 and FY 2023 will give 

FDA access to a full suite of products including:

1. A suite of manufacturing, product lifecycle 

development, and modeling software,

2. Process design and manufacturing modeling 

and simulation,

3. Change management and closed loop 

quality management, and

4. User stories that demonstrate the 

implementation of a fully digital product 

lifecycle implementation.

They will be connected to a miniature conveyor 

line and demonstration system providing a handson link to real-world sensors and personnel training 

opportunities. Internal and external research 

collaborations on the regulatory science benchmarks, metrics, and the needs of systems using 

these types of technologies will help create 

publicly available information and FDA internal 

expertise to appropriately and transparently review 

these processes.
35

FDA also continues to take creative and flexible 

approaches to address availability of critical medical 

products in response to the COVID-19 pandemic, 

and to prepare for future public health emergencies. 

FDA funded a study, completed in 2021, to increase 

the agency’s understanding of factors that impact a 

manufacturer’s decision to invest in and adopt digital 

technologies by identifying both perceived and demonstrated barriers. FDA also funded a study, completed 

by America Makes in 2021, to summarize the impact 

of 3D printing on the overall COVID-19 response. 

FDA made publicly available this report on the use of 

additive manufacturing by non-traditional producers 

in support of the U.S. COVID-19 response.

Under a 2020 MOU, FDA is partnering with the 

VA Innovation Ecosystem and the NIH 3D Print 

Exchange to share data and coordinate on opensource medical products for the COVID-19 response. 

This project resulted in millions of pieces of PPE and 

other medical devices being 3D-printed to support 

front-line COVID-19 response efforts. FDA and the 

U.S. Army Medical Logistics Command also continue 

information-sharing begun in previous years on additive manufacturing of medical devices and medical 

device components. FDA has a number of other active 

public-private partnerships and other industry 

and government consortia to support advanced manufacturing for emergency preparedness and response. 

Advanced manufacturing 

innovation around FDA

To support innovation in this field, FDA has led the 

world in advancing efforts to provide a comprehensive 

regulatory framework to manufacturers and a more 

effective pathway to getting state-of-the-art 

medical products into the hands of patients and health 

care providers. To date, FDA has cleared more than 

250 3D-printed medical devices and has approved a 

3D-printed drug, finished dosage forms, an active 

pharmaceutical ingredient, and biological molecules 

produced using advanced manufacturing technologies. 

Programs supporting advanced manufacturing for 

public health emergency preparedness and response 

around FDA include:

CDER

CDER’s Emerging Technology Program provides 

opportunities for early engagement regarding 

innovative approaches to pharmaceutical product 

design or manufacturing. Under this program, FDA 

has approved 16 regulatory submissions involving 

advanced manufacturing, including 12 that use 

continuous manufacturing. For example, to support 

COVID-19 response, FDA approved two supplemental 

applications that use advanced manufacturing in a U.S. 

facility to address the potential shortage of two critical 

drug products. 

CBER

The new CBER Advanced Technology Team was 

also started to promote communication between 

CBER and prospective innovators/developers of 

advanced manufacturing technologies. In FY 2022, 

CBER funded new research to enhance innovations 

in advanced manufacturing technologies for 

biologics products. Such technologies and processes 

may increase the domestic production of critical MCMs 

and other medical products needed for pandemic or 

other response activities. 

CDRH: 3D Printing of medical devices

The flexibility of 3D printing allows designers to make 

changes easily without the need to set up additional 

equipment or tools. It also enables manufacturers 

to create devices matched to a patient’s anatomy 

(patient-specific devices) or devices with very complex 

internal structures. These capabilities have sparked 

huge interest in 3D printing of medical devices and 

other products, including food, household items, 

3D printing and additive manufacturing

3D printing is a process that creates a threedimensional object by building successive layers 

of raw material. Each new layer is attached to the 

previous one until the object is complete. Objects 

are produced from a digital 3D file, such as a 

computer-aided design (CAD) drawing or a 

magnetic resonance image (MRI). 3D printing is a 

type of additive manufacturing. 

There are several types of additive manufacturing, but the terms 3D printing and additive 

manufacturing are often used interchangeably.
36

automotive parts, and—as noted earlier—producing 

PPE in response to COVID-19 shortages.

In 2017, FDA became the first regulator worldwide 

to provide a comprehensive technical framework to 

advise manufacturers creating medical products on 

3D printers, by issuing the guidance Technical 

Considerations for Additive Manufactured 

Medical Devices. Since releasing this guidance, 

FDA has worked closely with America Makes on a 

Standards Roadmap for 3D printing. FDA’s continued 

interaction with stakeholder groups, including the 

Department of Veterans Affairs Innovation Network, 

is facilitating advanced 3D-printed solutions that are 

reaching civilian and military patients.

In-house 3D printing: Additive Manufacturing 

of Medical Products (AMMP) 

FDA’s Additive Manufacturing of Medical Products 

(AMMP) core research facility is a multi-center 

collaboration. It augments center-specific resources 

and houses high-end, industry-grade 3D printing

equipment, software, and expertise that can be used 

across FDA to perform cutting-edge regulatory 

research with this advanced technology.

The AMMP Lab will establish a scientific foundation to assist FDA with its assessment of advanced 

manufacturing, and provide the critical infrastructure 

the agency will need to meet the regulatory demands of 

the future. FDA’s in-house 3D printing facilities enable 

FDA scientists to develop standards and metrics for 

use of 3D printing for medical products; conduct 

research to determine how the 3D printing of drugs 

3D-printed titanium spinal disc replacement, similar to those used 

to treat degenerative disc disease.

impacts active and inactive drug components; and 

identify critical quality processes and controls that 

affect the safety and performance of drugs and devices.

OCET

The OCET Advanced Manufacturing 

Program supports innovative, cross-cutting advanced 

manufacturing technologies to fill unmet regulatory 

science needs related to rapidly changing and 

disruptive needs. Cross-cutting platforms are typically 

technologies or processes that can be used in two or 

more FDA-regulated product areas. The program aims 

to build internal FDA expertise, develop regulatory 

science tools, and create consistent approaches to 

regulation, ultimately helping facilitate production of 

regulated products using these new technologies. 
37

MEDICAL COUNTERMEASURE 

REGULATORY POLICY

FDA continues efforts to ensure that the FDA MCM 

legal, regulatory, and policy framework enables 

the application of advances in regulatory science to 

the regulatory review process and adequately supports 

preparedness for and response to CBRN and emerging 

infectious disease threats by facilitating the development and availability of MCMs. In addition to 

addressing policy aspects of those activities described 

generally throughout this document, examples of 

FDA advancing policy-specific efforts in FY 2022, as 

discussed in more detail in other sections, include:

• Advancing efforts to create a national capability to 

track, collect, analyze, and evaluate information 

related to MCMs used during public health emergencies, including COVID-19 countermeasures, 

to inform real-time decisions about the safety and 

effectiveness of these MCMs.

• Addressing issues related to use of expanded 

access mechanisms and EUAs to make 

available unapproved MCMs for CBRN and other 

emerging infectious disease threats and for certain 

DoD-related threat agents.

• Supporting efforts to advance FDA capacities 

to monitor the MCM supply chain to identify 

product shortages and distribution of misbranded/

counterfeit products.

• Supporting an adequate supply of MCMs through 

efforts to extend the shelf life of certain MCMs 

outside of SLEP, utilizing authorities under section 

564A(b) of the FD&C Act.

• Leading or providing policy subject matter input 

to FDA MCM-related collaborations, including 

with DoD under PL 115-92.

• Maintaining a surveillance program that routinely 

monitors online sources for fraudulent products, 

especially during public health emergencies, such 

as COVID-19 and Ebola. 

• Updating regulatory policy to improve availability 

of blood and blood components, ensure adequate 

protections for donor health, and maintain a safe 

blood supply for patients.

• Clarifying regulatory issues around building 

frameworks for conducting clinical trials during 

public health emergencies.

• Participating in interagency emergency 

preparedness exercises and follow-up activities.

Seeking stakeholder input

To gather feedback from key stakeholders, including 

health care personnel and leadership, FDA and the 

Reagan-Udall Foundation held two EUA roundtable 

discussions in November 2021 to solicit input about 

EUA documentation and processes. 

In February 2022, FDA and the Reagan-Udall 

Foundation held a roundtable to gather stakeholder 

input on the use of master files for MCM development, 

and how to best improve the submission and use of 

master files for MCMs. This activity fulfilled a requirement under Section 603 of the Pandemic All Hazards 

Preparedness and Advancing Innovations Act of 2019 

(PAHPAIA).20

Developing new approaches

FDA also continued to implement MCM-related 

legislation and develop and propose new approaches 

for addressing legal, regulatory, and policy challenges 

associated with the development and use of MCMs. 

For example, FDA is:

• Continuing work to harmonize the multijurisdictional regulation of certain PPE that may 

be used during public health emergencies, such as 

COVID-19 and pandemic influenza.

• Continuing to address issues related to informa20 For more information on PAHPAIA, see MCM-Related Counterterrorism Legislation.
38

tion disclosure, including related to COVID-19 

interagency activities, and liability protections 

related to MCM products.

• Identifying and developing new legislative 

proposals, providing technical assistance on 

others’ MCM-related legislative proposals, and 

supporting MCM-related congressional testimony.

• Implementing MCM-related provisions of PAHPAIA 

(PL 116-22), which reauthorizes and modifies 

programs related to public health emergency 

preparedness and response and the Coronavirus 

Aid, Relief, and Economic Security Act (CARES Act) 

(PL 116-136), including identifying approaches for 

use of master files to facilitate MCM development.

• Established templates for notifying master file 

holders of reliance upon information held in the 

master file in accordance with section 603 of the 

FD&C Act as provided for in PAHPAIA.21

• Implementing MCM-related provisions of the 

Cures Act, including the material threat MCM 

priority review voucher (PRV) program by 

working to incorporate the draft guidance, 

issued in January 2018, into a comprehensive draft 

guidance on all FDA PRV programs. In addition, 

on October 7, 2022, FDA issued a notice

establishing the fee rate for using a PRV in FY 

2023, including material threat MCM PRVs. FDA 

issued one material threat MCM PRV in FY 2022, 

BOX 9: STRENGTHENING THE 

MCM SUPPLY CHAIN

FDA continues to work with U.S. and global 

manufacturers to address unprecedented 

disruptions in global supply chains, impacting 

medical products needed to respond to the 

COVID-19 pandemic. FDA monitors the MCM 

supply chain to identify product shortages and 

distribution of misbranded or counterfeit products. 

FDA contributed to the HHS-led Public Health 

Supply Chain and Industrial Base One-Year 

Report, published in February 2022, identifying 

practical strategies the USG can implement to address public health supply chain and industrial base vulnerabilities. The report covers PPE and durable medical equipment, testing and diagnostics, and pharmaceuticals and 

vaccines, under Executive Order 14017 on America’s Supply Chains. 

In 2020, FDA also published a list of essential medicines, MCMs, and critical inputs, to ensure that the 

U.S. is able to protect patients and our military forces against emerging infectious diseases, such as COVID-19 

as well as CBRN threats.

Preventing medical device shortages

During the COVID-19 pandemic, Section 506J was added to the FD&C Act (21 U.S.C. 356j) giving FDA certain 

authorities related to device shortages and potential device shortages occurring during or in advance of a public health emergency. This authority requires manufacturers to notify FDA of a permanent discontinuance in the 

manufacture of certain devices or an interruption in the manufacture of certain devices that is likely to lead to a 

meaningful disruption in supply of that device in the U.S. This provides the FDA with better visibility of the medical 

devices supply chain. FDA issued an immediately in effect guidance document, Notifying CDRH of a Permanent 

Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the 

COVID-19 Public Health Emergency, to implement section 506J of the FD&C Act. In FY 2021, FDA published a 

list of medical device types to help determine Section 506J notification obligations, and continues to update it, 

including adding new types of devices when circumstances warrant, or removing them when shortages resolve.

21 Public Law 116-22, Jun 24, 2019, 133 Stat. 905. 
39

and posted a notice of one redeemed material 

threat MCM PRV.

• Developing MCM-related guidance documents 

issued in FY 2022 (Appendix 3), key meetings 

and workshops (Appendix 4), and information for 

stakeholders about key MCM-related authorities.

• Supporting efforts to modernize the legal framework 

for regulating laboratory developed tests (LDTs) and 

other IVD tests made available during emergency 

circumstances, and working with CDC and CMS to 

leverage the expertise of each agency to collaborate 

on and address issues related to the implementation 

of EUA diagnostic tests in clinical and public health 

laboratories during public health emergencies. 

• Continuing to support development of the State 

Party Annual Report as required under the 

International Health Regulations and 

U.S. Health Security National Action Plan: 

Strengthening Implementation of the 

International Health Regulations based on 

the 2016 JEE, containing hundreds of crosssectoral activities to better prepare the U.S. to 

prevent, detect, and respond to public health 

emergencies. 

• Continuing to work to implement Public Law 

115-92, enacted in December 2017, which amended 

FDA’s EUA authorities to allow for emergency uses 

of medical products for threats in addition 

to CBRN agents, to include other agents that 

may cause or are otherwise associated with, an 

imminently life-threatening and specific risk to 

U.S. military forces.

• Continuing to work with DoD to implement Public 

Law 115-92’s provisions for enhanced engagements to expedite development and FDA’s review 

of products to diagnose, treat, or prevent serious 

or life-threatening diseases or conditions facing 

American military personnel.

• Supporting HHS’s GHSA through participation 

in the Research and Development and Legal 

Preparedness Action Packages.

• Drafting MOUs to provide frameworks for FDA 

collaborations.

PROFESSIONAL 

DEVELOPMENT

FDA launched the MCMi professional development program in FY 2011 to ensure that FDA 

scientists are informed about CBRN threats and 

associated health impacts as they conduct benefit-risk 

analyses on MCMs, and that FDA scientists can 

meet the regulatory challenges posed by new areas 

of science and technology in the area of MCM 

development.

Due to the COVID-19 pandemic, the MCMi 

professional development program held fewer training 

sessions than in previous years. Activities in FY 2022 

included: 

MCMi Lecture Series

These lectures, presented by highly respected leaders 

in their fields, broaden understanding of the policies, 

procedures, and U.S. governmental preparedness 

and response framework for FDA reviewers who are 

assessing MCM applications. FDA held 10 virtual 

lectures in this series during FY 2022 with a total of 

707 attendees. 
40

Foundations for Preclinical Review

Lecture Series

These lectures focus on preclinical scientific and 

technical issues of importance to MCM reviewers, since 

many MCMs are developed under the Animal Rule. 

Presentations cover topics that address a new procedure 

or infrastructure change and are targeted to FDA staff 

reviewing preclinical information in medical product 

applications. FDA held two virtual lectures in this series 

during FY 2022 with a total of 101 attendees.

MCMi Intramural Research and 

Collaborative Lecture Series 

This lecture series brings together the FDA research 

community to engage with FDA scientists supported 

by the MCMi Intramural Regulatory Science Program 

to share ideas and knowledge and inspire continued 

advancement in MCM regulatory science. These sessions 

are designed for an FDA audience, including scientists 

involved in the review of medical product applications. 

FDA held seven virtual lectures in this series during 

FY 2022 with a total of 606 attendees.

Data quality and integrity training for 

high-consequence pathogens

FDA also sponsored the 10th installment of a weeklong training course with the University of Texas 

Medical Branch (UTMB) to provide training on best 

practices to ensure the quality and integrity of data 

generated in maximum-containment (i.e., biosafety 

level (BSL)-3 and -4) laboratories used to support 

product approval under the Animal Rule. This course 

was held with virtual and in-person options April 

25-29, 2022, with 173 total participants.

FDA and UTMB also held the third annual clinical 

course, Achieving Data Quality and Integrity in 

Clinical Trials Involving High-Consequence 

Pathogens with virtual and in-person options on 

July 11-13, 2022, with 183 total participants. This 

course is designed to provide a learning environment 

that cultivates collaboration of ideas; yields tools for 

clinical study conduct; enhances mutual understanding of clinical, scientific, and regulatory complexities; 

and promotes the data quality and integrity derived 

from these regulated studies according to good clinical 

practice (GCP) principles.
41

APPENDIX 1: FY 2022 MEDICAL COUNTERMEASURE 

APPROVALS – BIOLOGICS AND DRUGS

This list includes MCMs approved, licensed, or cleared by FDA in FY 2022 

(October 1, 2021 - September 30, 2022). Additional information can be found on our website at:

• For products (biologics) regulated by CBER: Biologics Products & Establishments

• For products (drugs and biologics) regulated by CDER: Drugs@FDA: FDA-Approved Drugs

and The Purple Book Database of Licensed Biological Products

Medical 

Countermeasure Applicant Key Dates Indication

Comirnaty COVID-19 

Vaccine, mRNA

BioNTech 

Manufacturing 

GmbH

• Submitted 

December 16, 2021

• Approved 

July 8, 2022

BLA supplement to include use of this vaccine in 

adolescents 12 through 15 years of age for active 

immunization to prevent COVID-19 caused by 

SARS-CoV-2.

Ervebo Ebola Zaire 

Vaccine, Live

Merck Sharp 

& Dohme 

Corp.

• Submitted 

March 21, 2022

• Approved 

September 16, 2022

BLA supplement to revise the package insert 

based upon Study V920-018 conducted in frontline workers. Ervebo is a vaccine indicated for the 

prevention of disease caused by Zaire ebolavirus

in individuals 18 years of age and older.

Flucelvax 

Quadrivalent 

Influenza Vaccine

Seqirus, Inc. • Submitted 

December 14, 2020

• Approved 

October 14, 2021

BLA supplement to extend use to persons 6 

months of age and older. Flucelvax Quadrivalent is 

approved for active immunization for the prevention of influenza disease caused by influenza virus 

subtypes A and types B contained in the vaccine.

Jynneos Smallpox 

and Monkeypox 

Vaccine, Live, 

Non-Replicating

Bavarian 

Nordic

• Submitted 

May 6, 2022

• Approved 

September 2, 2022

BLA supplement to allow additional doses 

manufactured at a facility in Europe to be further 

distributed and administered in the U.S.

Midazolam Injection, 

10 mg/0.7 mL

(autoinjector)

Rafa 

Laboratories, 

Ltd.

• Submitted 

March 28, 2022

• Approved 

August 8, 2022

Indicated for the treatment of status epilepticus in 

adults. This could include treatment of seizures 

resulting from nerve agent exposure.

Naloxone 

Hydrochloride 

Injection, 10 mg

(autoinjector)

Kaleo, Inc. • Submitted 

August 31, 2021

• Approved 

February 28, 2022

For use by military personnel and chemical incident 

responders for emergency treatment of patients 12 

years of age and older where use of high-potency 

opioids such as fentanyl analogues as a chemical 

weapon is suspected, or temporary prophylaxis of 

respiratory and/or central nervous system depression in military personnel and chemical incident 

responders entering an area contaminated with 

high-potency opioids such as fentanyl analogues.
42

Medical 

Countermeasure Applicant Key Dates Indication

Olumiant (baricitinib) Eli Lilly 

and Co.

• Submitted 

November 10, 2021

• Approved 

May 10, 2022

Supplemental NDA for the treatment of COVID-19 

in hospitalized adults requiring supplemental 

oxygen, noninvasive or invasive mechanical 

ventilation, or ECMO.

Spikevax COVID-19 

Vaccine, mRNA

ModernaTx, 

Inc.

• Submitted 

August 21, 2021

• Approved 

January 31, 2022

For active immunization to prevent COVID-19 

caused by SARS-CoV-2 in individuals 18 years of 

age and older.

TPOXX (tecovirimat) 

injection

Siga 

Technologies, 

Inc.

• Submitted 

April 30, 2021

• Approved 

May 18, 2022

Approval of an IV formulation for the treatment of 

human smallpox disease caused by variola virus 

in adults and pediatric patients weighing at least 

3 kg. The IV formulation is an option for those 

who are unable to swallow the oral capsule. This 

approval expanded the eligible population from 

patients weighing at least 13 kg down to patients 

weighing at least 3 kg.

TPOXX (tecovirimat 

capsule, for oral use)

Siga 

Technologies, 

Inc.

• Submitted 

April 18, 2022

• Approved 

May 18, 2022

Supplemental NDA approval expanding the 

patient population to include pediatric patients 

weighing at least 3 kg. The original approval in 

2018 was for adult and pediatric patients weighing 

at least 13 kg. 

Veklury (remdesivir) 

injection

Gilead 

Sciences, Inc.

• Received 

October 21, 2021

• Approved 

January 21, 2022

NDA supplement for use as a 3-day dosing 

regimen for the treatment of COVID-19 in adults 

and pediatric patients (12 years of age and 

older and weighing at least 40 kg) with positive 

results of direct SARS-CoV-2 viral testing, who 

are not hospitalized and have mild-to-moderate 

COVID-19, and are at high risk for progression 

to severe COVID-19, including hospitalization 

or death.

Veklury (remdesivir) 

injection

Gilead 

Sciences, Inc.

• Received 

November 30, 2021

• Approved April 25, 

2022

NDA supplement for treatment of COVID-19 

in pediatric patients (28 days of age and older 

weighing at least 3 kg [about 7 pounds)] to less 

than 40 kg) with positive results of direct 

SARS-CoV-2 viral testing, who are hospitalized, 

or not hospitalized and have mild-to-moderate 

COVID-19 and are at high risk for progression 

to severe COVID-19, including hospitalization 

or death.

Xofluza 

(baloxavir marboxil)

Genentech, 

Inc.

• Received 

January 23, 2020

• Approved 

August 11, 2022

NDA supplement for the treatment of influenza 

and for post-exposure prophylaxis of influenza in 

in a new population, pediatric patients ≥ 5 to less 

than 12 years of age. 
43

APPENDIX 2: FY 2022 MEDICAL COUNTERMEASURE 

APPROVALS – DEVICES

This list includes MCMs approved, licensed, or cleared by FDA in FY 2022 (October 1, 2021 - 

September 30, 2022). Additional about device approvals can be found on our website at Medical Devices 

Databases, including the 510(k) Premarket Notification Database.

Diagnostic Tests

Medical 

Countermeasure Applicant Key Dates Indication

BioFire COVID-19 

Test 2

BioFire 

Diagnostics, 

LLC

K211079 

• Received 

April 12, 2021

• Cleared 

November 1, 2021

K221460

• Received 

May 19, 2022

• Cleared 

July 25, 2022

For the qualitative detection of nucleic acids 

(SARS-CoV-2 RNA) in nasopharyngeal swabs 

(NPS) from symptomatic individuals suspected of 

COVID-19. (K211079)

In FY 2022, FDA cleared an additional 510(k) 

(K221460) to display results for four additional 

SARS-CoV-2 assays which were present on the 

test, but for which results were masked through 

software. The assays were unmasked as a 

mitigation against the risk of future SARS-CoV-2 

variants affecting the sensitivity of the test due to 

mutations in assay primer regions.

cobas Influenza A/B & 

RSV nucleic acid test 

for use on the cobas 

Liat System

Roche 

Molecular 

Systems, Inc.

• Received 

December 8, 2021

• Cleared 

July 6, 2022

The cobas Influenza A/B & RSV Nucleic acid test 

was cleared in 2021 (K210234) for the qualitative 

detection of Influenza A, Influenza B, and respiratory syncytial virus (RSV) RNA in NPS specimens. 

In 2022, FDA cleared (K213822) a modification of 

the negative control and positive control diluent to 

a functionally equivalent buffer

ID Now Instrument, ID 

Now Influenza A & B 2, 

ID NOW Strep A 2

Abbott 

Diagnostics 

Scarborough, 

Inc.

• Received 

March 18, 2022

• Cleared 

June 24, 2022

The Alere i Influenza A & B 2 test was cleared in 

2017 (K171792) for the qualitative detection and 

discrimination of influenza A and B viral RNA in 

direct nasal or nasopharyngeal swabs and nasal 

or nasopharyngeal swabs eluted in viral transport 

media from patients with signs and symptoms 

of respiratory infection. In 2022, FDA cleared 

(K220801) a modification of the ID Now 

Instrument software to mitigate issues with false 

invalid results due to low baseline values.
44

Medical 

Countermeasure Applicant Key Dates Indication

Non-variola 

Orthopoxvirus 

Real-time PCR Primer 

and Probe Set

CDC K221658

• Received 

June 8, 2022

• Cleared 

June 10, 2022

K221834

• Received 

June 23, 2022

• Cleared 

June 24, 2022

K222558

• Received 

August 24, 2022

• Cleared 

August 30, 2022

A CDC test was cleared in 2018 (K181205) for 

in vitro qualitative presumptive detection of nonvariola Orthopoxvirus DNA extracted from human 

pustular or vesicular rash specimens and viral cell 

culture lysates submitted to an LRN reference 

laboratory. In 2022, FDA cleared additional 

510(k)s from CDC, which expanded testing 

capacity through use:

• of additional reagents and automation 

(K221658; cleared June 10, 2022),

• in CDC-designated laboratories outside the LRN 

(K221834; cleared June 24, 2022), and

• of new extraction platform options, among other 

changes (K222558; cleared August 30, 2022).

Simplexa COVID-19

Direct, Simplexa 

COVID-19 Positive 

Control Gen II Pack

DiaSorin 

Molecular 

LLC

• Received 

July 9, 2021

• Cleared 

September 13, 2022

For the qualitative detection of nucleic acids 

(SARS-CoV-2 RNA) in NPS and nasal swabs 

(NS) from symptomatic individuals suspected of 

COVID-19.

Other MCM Devices (Non-COVID-Related)

Medical 

Countermeasure Applicant Key Dates Indication

MY01 Continuous 

Compartmental 

Pressure Monitor

MYO1, Inc. • Received 

April 1, 2022

• Cleared 

May 24, 2022

The MY01 Continuous Compartmental Pressure 

Monitor is used for real-time and continuous measurement of the muscle compartment pressure. 

The measured muscle compartment pressure can 

be used as an aid in diagnosis of compartment 

syndrome (acute and chronic). The MY01 Mobile 

Application is an application intended for storing 

and displaying identical pressure values from the 

MY01 Continuous Compartmental Pressure Monitor device and calculating critical muscle perfusion 

pressure utilizing diastolic pressure manual entry 

by the physician. Diagnosis should always be 

made in conjunction with clinical assessments.

Zeolite Hemostatic 

Gauze

Hangzhou 

Zeo-Innov 

Life 

Technology 

Co., Ltd.

• Received 

May 21, 2021

• Cleared 

February 10, 2022

The Zeolite Hemostatic Gauze was cleared for 

prescription use for temporary external use to 

control traumatic bleeding. It was also cleared 

for over-the-counter use intended for temporary external use to stop bleeding of superficial 

wounds, minor cuts, and abrasions.
45

COVID-19 Related Device Clearances 

In addition to the diagnostic tests listed in the previous table, FDA cleared 708 other COVID-19-related medical 

devices in FY 2022:

 

• 390 PPE devices, including gloves, surgical masks, and gowns

• 11 dialysis-related products

• 59 general intensive care unit (ICU)/hospital products

• 37 infusion pumps and related accessories

• 55 needles and syringes

• 30 sterilization products

• 26 ventilation-related products

• 100 vital sign monitoring products

Additional information about these device approvals can be found in the FDA Medical Devices Databases, 

including the 510(k) Premarket Notification Database. To locate records for a particular type of product 

(vs. specific product by name), use the Product Classification Database to find the product code assigned to 

that type of device, and search FDA medical device databases for that product code. 

Product codes are assigned based upon the medical device product classification designated under 21 CFR Parts 

862-892. For more information, see Product Code Classification Database.

Product codes for PPE include:

• LZA - Polymer patient examination glove

• LZC - Patient examination glove, specialty

• FYA - Gown, surgical

• KGO - Surgeon’s gloves

• LYY - Latex patient examination glove

• FXX - Mask, surgical

• FYC - Gown, isolation, surgical

• LYZ - Vinyl patient examination glove

• OXZ - Pediatric/child facemask

Product codes for cleared dialysis related devices:

• FJK - Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

• KDL - Set, Perfusion, Kidney, Disposable

• KDI - Dialyzer, High Permeability With Or Without Sealed Dialysate System
46

• KDJ - Set, Administration, For Peritoneal Dialysis, Disposable

• KPO - Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

Product codes for cleared general ICU/hospital products:

• PIF - Gastrointestinal Tubes With Enteral Specific Connectors

• EOQ - Bronchoscope (Flexible Or Rigid)

• LHI - Set, I.V. Fluid Transfer

• EZL - Catheter, Retention Type, Balloon

• KNT - Tubes, Gastrointestinal (And Accessories)

• KOD - Catheter, Urological

• KTI - Bronchoscope Accessory

• FRA - Purifier, Air, Ultraviolet, Medical

• FMK - Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

• FRF - Cleaner, Air, Medical Recirculating

Product codes for cleared infusion pumps and related accessories:

• PTI - Non-Coring (Huber) Needle

• FOZ - Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

• FRN - Pump, Infusion

• FPA - Set, Administration, Intravascular

• MRZ - Accessories, Pump, Infusion

• LJS - Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

• PND - Midline Catheter

• FMG - Stopcock, I.V. Set

• PMS - Peripheral Intravenous (Piv) Infiltration Monitor

Product codes for cleared needles and syringes:

• FMF - Syringe, Piston

• FMI - Needle, Hypodermic, Single Lumen

• MEG - Syringe, Antistick

•QEH - Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spina

Fluid Contact
47

Product codes for cleared sterilization products:

• MLR - Sterilizer, Chemical

• KCT - Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

• FLE - Sterilizer, Steam

• MED - Sterilant, Medical Devices

Product codes for cleared ventilation related products:

• BTR - Tube, Tracheal (W/Wo Connector)

• KFM - Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

• CBK - Ventilator, Continuous, Facility Use

• DWF - Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

• CAH - Filter, Bacterial, Breathing-Circuit

• DTZ - Oxygenator, Cardiopulmonary Bypass

• BZD - Ventilator, Non-Continuous (Respirator)

• DTR - Heat-Exchanger, Cardiopulmonary Bypass

• BTT - Humidifier, Respiratory Gas, (Direct Patient Interface)

• CAW - Generator, Oxygen, Portable

• DWC - Controller, Temperature, Cardiopulmonary Bypass

• MNT - Ventilator, Continuous, Minimal Ventilatory Support, Facility Use

Product codes cleared for vital sign monitoring:

• DPS - Electrocardiograph

• DYB - Introducer, Catheter

• MWI - Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

• MHX - Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

• FLL - Thermometer, Electronic, Clinical

• DQA - Oximeter

• DXT - Injector And Syringe, Angiographic

• DQD - Stethoscope, Electronic

• BZQ - Monitor, Breathing Frequency

• MSX - System, Network And Communication, Physiological Monitors

• DRG - Transmitters And Receivers, Physiological Signal, Radiofrequency

• DRT - Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
48

APPENDIX 3: MCM-RELATED GUIDANCE ISSUED IN FY 2022

In FY 2020 through FY 2022, FDA issued more than 75 COVID-19-related guidances, to provide timely 

recommendations, regulatory information, guidance, and technical assistance necessary to support rapid response 

efforts to the COVID-19 public health emergency. Only MCM-related guidances are included below; the full list of 

current COVID-19-related guidance documents is available on the FDA website.

22 Note that some COVID-19 

guidance documents may have been updated once or more since issuance. The date listed in this table for all 

documents refers to the most recent update available at the end of FY 2022 (September 30, 2022). Some guidances may be temporary, that is, only in effect during the COVID-19 public health emergency, or until further 

notice. Accordingly, some guidances in the table below have been subsequently modified or revoked in the time 

period not covered by this report.

This table includes guidance documents designed to address MCM-specific topics and guidance documents 

that address more general topics considered to have likely relevance to some aspects of MCM development. 

It is not intended as a comprehensive list of all guidance documents; some product sponsors may find additional 

relevant documents on the FDA guidance website.

Date Guidance 

Type Guidance Name Purpose

November 8, 2021 Final Manufacture of Blood 

Components Using a 

Pathogen Reduction 

Device in Blood Establishments: Questions 

and Answers (link)

To provide blood establishments that collect or 

process blood and blood components with 

recommendations for implementing a pathogen 

reduction device for the manufacture of 

pathogen-reduced blood components.

November 15, 2021 Final (revised) Enforcement Policy for 

Viral Transport Media 

During the Coronavirus 

Disease 2019 

(COVID-19) Public 

Health Emergency 

(Revised) (link)

To help facilitate the availability of devices for 

use in transporting certain clinical specimens, 

including transport media that can be used to 

transport certain clinical specimens for use with 

molecular Reverse Transcriptase-Polymerase 

Chain Reaction (RT-PCR) SARS-CoV-2 assays or 

antigen-detection diagnostic SARS-CoV-2 assays 

for the duration of the COVID-19 public health 

emergency.

22 Also see, in the Federal Register, Process for Making Available Guidance Documents Related to Coronavirus Disease 2019.
49

Date Guidance 

Type Guidance Name Purpose

December 10, 2021 Final Policy for Certain 

REMS Requirements 

During the Tocilizumab 

Shortage Related to 

the COVID-19 Public 

Health Emergency

To communicate FDA’s temporary policy with 

respect to certain REMS requirements for 

tocilizumab due to the shortage related to the 

COVID-19 public health emergency. This 

guidance will remain in effect for the duration 

of the tocilizumab shortage. FDA is continually 

assessing the needs and circumstances related 

to this temporary policy. As relevant needs and 

circumstances evolve, FDA intends to update, 

modify, or withdraw this policy as appropriate. 

This product is authorized under EUA for treatment of COVID-19 in hospitalized adults and 

pediatric patients (2 years of age and older) who 

are receiving systemic corticosteroids and require 

supplemental oxygen, non-invasive or invasive 

mechanical ventilation, or ECMO.

December 22, 2021 Draft Transition Plan for 

Medical Devices 

Issued EUAs During 

the COVID-19 Public 

Health Emergency 

(link)

To provide recommendations and expectations to 

manufacturers of devices that were issued EUAs 

to transition back to normal operations when 

the emergency use declarations that allowed for 

FDA to issue EUAs are no longer in effect. FDA 

believes the policy set forth in this guidance may 

help FDA and other stakeholders transition from 

COVID-19 operations and processes to normal 

operations and processes.

December 22, 2021 Draft Transition Plan 

for Medical Devices 

That Fall Within 

Enforcement 

Policies Issued During 

the COVID-19 

Public Health 

Emergency (link)

To provide recommendations and expectations to 

manufacturers of devices that fell within enforcement policies to transition back to normal operations when the public health emergency expires. 

FDA believes the policy set forth in this guidance 

may help FDA and other stakeholders transition 

from COVID-19 operations and processes to 

normal operations and processes.

December 23, 2021 Draft Technical 

Considerations for 

Medical Devices 

with Physiologic 

Closed-Loop Control 

Technology (link)

To provide FDA’s recommendations on design 

considerations, nonclinical testing, animal studies, 

and labeling to support premarket submissions 

for medical devices with physiologic closed-loop 

control technology.
50

Date Guidance 

Type Guidance Name Purpose

January 7, 2022 Final (revised) Investigational 

COVID-19 

Convalescent Plasma 

(link)

To provide recommendations to health care 

providers and investigators on the use of 

COVID-19 convalescent plasma or investigational 

convalescent plasma during the public health 

emergency, and to provide recommendations to 

blood establishments on collection. FDA revised 

the guidance in January 2022, to reflect that the 

EUA authorizes COVID-19 convalescent plasma 

with high titers of anti-SARS-CoV-2 antibodies 

for the treatment of COVID-19 in patients with 

immunosuppressive disease or receiving immunosuppressive treatment in either the outpatient 

or inpatient setting, and revise certain recommendations pertaining to COVID-19 convalescent 

plasma donors. 

February 4, 2022 Final Nonclinical Considerations for Mitigating 

Nonhuman Primate 

Supply Constraints 

Arising from the 

COVID-19 Pandemic 

(link)

To help sponsors mitigate the challenges related 

to the constrained supply of NHPs available for 

conducting nonclinical toxicity assessments, 

which has arisen as a consequence of the current 

COVID-19 pandemic.

February 7, 2022 Final COVID-19 Public 

Health Emergency 

Policy on 

COVID-19-Related 

Sanitation Tunnels 

(link)

Because of significant concerns for human 

safety, to discourage sponsors from developing 

or seeking approval or authorization for the use 

of sanitation tunnels, also known as disinfection 

tunnels or sanitizing tunnels. Sanitation tunnels 

are tunnels, walkways, chambers, and similar 

systems that use sensor-based nozzles to spray 

humans (and their clothing) with a mist of 

disinfectant or aerosolized antiseptic as they 

walk or ride through these tunnels. First installed 

in China, these tunnels have been developed 

in countries outside of the U.S. with the aim of 

treating or reducing the spread of COVID-19. 

Sanitation tunnels are generally located outside 

crowded places such as food markets, shopping 

malls, hospitals, police stations, airports and train 

stations, offices, and industrial complexes.

March 31, 2022 Final (revised) Emergency Use 

Authorization for 

Vaccines to Prevent 

COVID-19 (link)

To provide recommendations for vaccine 

sponsors regarding the scientific data and 

information that would support the issuance of 

an EUA for an investigational vaccine intended to 

prevent COVID-19. 

April 8, 2022 Final Cybersecurity in 

Medical Devices: 

Quality System 

Considerations and 

Content of Premarket 

Submissions (link)

To provide recommendations to industry regarding 

cybersecurity device design, labeling, and the 

documentation that FDA recommends be included 

in premarket submissions for devices with 

cybersecurity risk.
51

Date Guidance 

Type Guidance Name Purpose

May 4, 2022 Final (revised) Supplements for 

Approved Premarket 

Approval (PMA) or 

Humanitarian Device 

Exemption (HDE) 

Submissions During the 

Coronavirus Disease 

2019 (COVID-19) 

Public Health Emergency (Revised) (link)

To provide a policy to help address current 

manufacturing limitations or supply chain issues 

due to disruptions caused by the COVID-19 

public health emergency.

May 20, 2022 Draft Risk Management 

Plans to Mitigate the 

Potential for Drug 

Shortages (link)

To help stakeholders develop, maintain, and 

implement risk management plans to proactively 

assist in the prevention of human drug product and 

biological product shortages. Risk management 

plans can provide stakeholders with a framework 

to proactively identify, prioritize, and implement 

strategies to mitigate hazards that can cause a 

supply disruption. 

September 13, 2022 Final Policy for Monkeypox 

Tests to Address 

the Public Health 

Emergency (link)

To describe FDA’s review priorities of EUA requests 

for monkeypox diagnostic tests and FDA’s enforcement policies for certain diagnostic tests that 

are developed by and performed in a laboratory 

certified under the Clinical Laboratory Improvement 

Amendments (CLIA) that meets the requirements 

to perform tests of high complexity; provide recommendations for diagnostic test validation; describe 

FDA’s enforcement policies for FDA-cleared or 

authorized monkeypox diagnostic tests that are 

modified; and describe FDA’s enforcement policies 

for certain serology tests.

September 27, 2022 Final (revised) Policy for Coronavirus 

Disease-2019 Tests 

During the Public 

Health Emergency 

(Revised) (link)

To provide FDA’s review priorities and enforcement policies regarding COVID-19 tests for the 

duration of the public health emergency.

September 28, 2022 Final Policy for Device 

Software Functions 

and Mobile Medical 

Applications (link)

To communicate how FDA intends to apply its 

regulatory oversight to certain software, including 

device software functions and mobile medical 

applications (MMAs) intended for use on mobile 

platforms or on general-purpose computing 

platforms.

September 28, 2022 Final Medical Device Data 

Systems, Medical 

Image Storage 

Devices, and Medical 

Image Communications Devices (link)

To communicate how FDA intends to apply its 

regulatory oversight to medical device data 

systems (MDDS), medical image storage devices, 

and medical image communication devices.

September 28, 2022 Final Display Devices for 

Diagnostic Radiology 

(link)

To provide FDA’s recommendations regarding premarket notification (510(k)) submissions for display 

devices intended for use in diagnostic radiology.
52

Date Guidance 

Type Guidance Name Purpose

September 28, 2022 Final Clinical Performance 

Assessment: 

Considerations for 

Computer-Assisted 

Detection Devices 

Applied to Radiology 

Images and 

Radiology Device 

Data in Premarket 

Notification (510(k)) 

Submissions (link)

To provide FDA’s recommendations on 

clinical performance assessments to support 

premarket notification (510(k)) submissions for 

computer-assisted detection (CADe) devices 

applied to radiology images and radiology device 

data. This guidance applies to CADe devices, 

including when a CADe device is part of a 

combined system, such as the detection portion 

of combined computer-aided detection and 

diagnostic devices.

September 28, 2022 Final Clinical Decision 

Support Software 

(link)

This final guidance clarifies FDA’s thinking 

expressed in the September 2019 draft guidance 

and focuses on clarifying the types of clinical 

decision support (CDS) software functions that 

are excluded from the definition of device by the 

criteria in section 520(o)(1)(E) of the FD&C Act 

(“Non-Device CDS criteria”). The final guidance 

further clarifies that FDA’s existing digital health 

policies continue to apply to software functions 

that meet the definition of a device, including 

those that are intended for use by patients or 

caregivers. 

September 29, 2022 Final Computer-Assisted 

Detection Devices 

Applied to Radiology 

Images and Radiology 

Device Data - 

Premarket Notification 

[510(k)] Submissions 

(link)

To provide FDA’s recommendations regarding 

premarket notification (510(k)) submissions for 

CADe devices applied to radiology images and 

radiology device data.
53

APPENDIX 4: KEY MCM-RELATED MEETINGS HELD IN FY 2022

FDA continued to take steps to ensure the agency was able to continue our vital public health mission in FY 2022. 

Where possible the agency leveraged technology to host meetings allowing for remote participation. We also 

continue to explore meeting platforms and formats, including pre-recorded presentations. This continued 

assessment is necessary as we respond to the challenges presented by the pandemic. The format for any meeting 

will be based on the discussion, advice, and recommendation that FDA needs from the committee as well as the 

requirements under the Federal Advisory Committee Act, if applicable. 

This table includes FDA-sponsored meetings intended to address MCM-specific topics, or more general 

FDA-sponsored meetings that may be relevant to some aspects of MCM development, that are open to the public. 

In some cases, FDA may have provided funding to support certain meetings hosted by others (e.g., NASEM).

Date Type of 

Event Event Name Purpose

Weekly or biweekly 

March 2020 through 

September 2022

Webinar 

series

Virtual Town Hall 

Series – Test 

Development and 

Validation During 

Public Health 

Emergencies (link)

To help answer technical questions about the 

development and validation of tests for 

SARS-CoV-2. This series began in March 2020, 

and continues in FY 2023, including COVID-19 

and mpox.

October 5, 2021 Webinar Enhanced Drug 

Distribution Security 

in 2023 Under the 

DSCSA (link)

To 1) Discuss enhanced drug distribution security 

requirements that go into effect in 2023 under 

the Drug Supply Chain Security Act (DSCSA); 

2) Explain how enhanced drug distribution security 

will help protect patients from exposure to drugs 

that may be counterfeit, stolen, contaminated, 

or otherwise harmful; and 3) Summarize updates 

on implementation of supply chain security 

requirements under the DSCSA.

October 14-15, 2021 Advisory 

Committee

Vaccines and Related 

Biological Products 

Advisory Committee 

(VRBPAC) (link)

To discuss the use of booster doses of the 

Moderna COVID-19 Vaccine and the Janssen 

COVID-19 Vaccine, and hear presentations and 

discuss the available data on the use of a booster 

of a different vaccine than the one used for the 

primary series of an authorized or approved 

COVID-19 vaccine (heterologous or “mix and 

match” booster).

October 26, 2021 Advisory 

Committee

VRBPAC (link) To discuss Pfizer Inc.’s request to amend its 

EUA to allow for the use of the Pfizer-BioNTech 

COVID-19 vaccine in children 5 through 11 years 

of age. 
54

Date Type of 

Event Event Name Purpose

November 8-9, 2021 Public 

workshop

13th Annual Sentinel 

Initiative Public 

Workshop (link)

To highlight milestones and strategic initiatives 

underway to enhance and build a more robust 

Sentinel Initiative, and discuss opportunities to 

utilize Sentinel’s existing data, infrastructure, and 

technology. The Sentinel system is a national 

electronic system for medical product safety 

surveillance.

November 9, 2021 Webinar FDA Center of Excellence in Regulatory 

Science and Innovation (CERSI) Lecture 

on Long COVID: Risk 

factors, Symptomology 

and Patient Reported 

Outcomes (link)

To review the known epidemiology of post-COVID 

conditions, and describe the methodological 

approach and data collection strategy of the 

CDC-funded Innovative Support for Patients with 

SARS-CoV-2 Infections (INSPIRE) study.

November 16, 2021 Webinar Enhanced Drug 

Distribution Security 

at the Package Level 

Under the DSCSA 

(link)

To provide members of the pharmaceutical distribution supply chain and other interested stakeholders an opportunity to discuss enhanced drug 

distribution security requirements of the DSCSA 

related to system attributes necessary to enable 

secure tracing of product at the package level.

November 30, 2021 Advisory 

Committee

Antimicrobial Drugs 

Advisory Committee 

(AMDAC) meeting 

(link)

To discuss Merck and Ridgeback’s request for an 

EUA for molnupiravir, an investigational antiviral 

drug to treat COVID-19. The committee discussed 

available data supporting the use of molnupiravir 

to treat mild-to-moderate COVID-19 in adults who 

have tested positive for COVID-19, and who are 

at high risk for progression to severe COVID-19, 

including hospitalization or death.

December 7-8, 2021 Webinar Clinical 

Investigator Training 

Course (CITC) Update 

(link)

Update to annual course, including a review of the 

development and emergency use authorization of 

medical products for the prevention and treatment 

of COVID-19, and investigator responsibilities 

during the pandemic.

December 14, 2021 Webinar Overview of Expanded 

Access (EA) Program 

and EA eRequest Site 

(link)

EA is use of an investigational drug or biologic to 

treat a patient with a serious disease or condition 

who does not have comparable or satisfactory 

alternative therapies. This webinar provided an 

overview of FDA’s EA Program and introduced 

participants to resources like the EA eRequest 

site hosted by the Reagan-Udall Foundation 

for the FDA. The EA eRequest site enables 

physicians to prepare and sign EA requests and 

submit those requests securely to FDA.

December 14, 2021 Webinar Webinar on Final Rule 

for Medical Device 

De Novo Classification 

Process (link)

To describe background and history of the 

De Novo Program, and provide updates on new 

regulations and changes to the De Novo review 

process, including what is required for acceptance 

of a De Novo request. 
55

Date Type of 

Event Event Name Purpose

February 22, 2022 Webinar Webinar on Draft 

Guidances on 

Transition Plans for 

COVID-19 Related 

Medical Devices (link)

To help prepare manufacturers and other stakeholders for the orderly and transparent transition 

to normal operations, describe recommendations 

regarding submitting a marketing submission and 

the timeline for doing so, provide examples to 

illustrate the transition policies and exemplify the 

180-day transition period timeline, and answer 

questions about the draft guidance on COVID-19 

transition plans.

March 3, 2022 Advisory 

Committee

VRBPAC (link) To discuss and make recommendations on 

the selection of strains to be included in the 

influenza virus vaccines for the 2022-2023 

influenza season.

March 7-9, 2022 Public 

workshop

Good Clinical Practice 

Workshop: Global 

Clinical Trials - 

Considerations and 

Lessons Learned 

from the Changing 

Landscape (link)

Hosted by FDA, the UK Medicines and 

Healthcare products Regulatory Agency (MHRA), 

and Health Canada, to provide attendees with 

insight into key topics, compliance trends and 

the opportunity to hear first-hand from regulators 

about lessons learned from the changing clinical 

trial landscape, including the use of innovative 

tools and approaches to trial design, conduct, 

and inspections.

March 16-17, 2022 Public 

workshop

Virtual Public Workshop - 3D Printing in 

Hospitals: Veteran’s 

Health Administration’s 

Experiences in Point 

of Care 3D Printing of 

Device and Implementing a Quality Management System (link)

In collaboration with the Veterans Health 

Administration (VHA), to share VHA’s experiences 

using 3D printing/additive manufacturing in their 

hospitals, and provide a forum for VHA and 

other stakeholders to present and discuss their 

experience that could be useful for health care 

facilities considering 3D printing medical devices. 

March 23-24, 2022 Public 

workshop

Identification of 

Concepts and 

Terminology for 

Multi-Component 

Biomarkers (link)

To develop multi-component biomarker concepts 

and terminology, to identify areas of conceptual 

language development through presentation 

of use cases, and discuss gaps in terminology 

for concepts and approaches related to multicomponent biomarkers.

April 6, 2022 Advisory 

Committee

VRBPAC (link) To discuss considerations for future 

COVID-19 vaccine booster doses and the process 

for selecting specific strains of the SARS-CoV-2 

virus for COVID-19 vaccines to address current 

and emerging variants.

April 25-29, 2022 Training 

course

Achieving Data 

Quality and Integrity in 

Maximum Containment 

Laboratories (link)

To provide training on best practices to ensure 

the quality and integrity of data generated in 

maximum-containment (i.e., biosafety level 

(BSL)-3 and -4) laboratories used to support 

product approval under the Animal Rule.
56

Date Type of 

Event Event Name Purpose

April 28-29, 2022 Webinar 2022 Sentinel 

Innovation Day and 

Public Training

To explore challenges and opportunities in 

integrating electronic health record-based 

data in common data models, computable 

phenotyping to aid medical product safety 

investigations, advanced analytic approaches 

to improve confounding adjustments in Sentinel 

investigations, and a causal inference framework 

for Sentinel, and discuss Inverse Probability of 

Treatment Weighting (IPTW), an analytic method 

that can reduce confounding bias in observational 

studies of medical treatments.

May 24-25, 2022 Public 

workshop

Translational Science 

in Drug Development: 

Surrogate Endpoints, 

Biomarkers, and More 

(link)

Hosted by FDA and the Duke-Margolis Center for 

Health Policy, to present best practices and use 

cases for successfully bringing forward evidence 

generated through translational science for regulatory submissions. Stakeholders will discuss ways 

that translational science can contribute to drug 

development programs (e.g., surrogate endpoints, 

enrichment biomarkers, biodynamic/response 

biomarkers), what some of the challenges are 

(e.g., validating biomarkers, establishing analytic 

validation, obtaining biosamples) and strategies 

to address those challenges (e.g., public-private 

partnerships, collaborations between industry 

and academia).

June 6-10, 2022 Conference Regulatory Education 

for Industry (REdI) 

Annual Conference 

2022 (link)

To provide participants with a strong, basic 

foundation in the FDA’s regulatory requirements, 

and create awareness of current activities, 

including a plenary session on some of FDA’s 

noteworthy milestones and landmark 

accomplishments during the COVID-19 response.

June 7, 2022 Advisory 

Committee

VRBPAC (link) To discuss an EUA request by Novavax for a 

vaccine to prevent COVID-19 in individuals 18 

years of age and older.

June 7-9, 2022 Public 

workshop

Building Medical 

Device Supply 

Chain Resilience: 

A Healthcare and 

Public Health 

Ecosystem-Wide 

Collaboration (link)

To discuss ways to foster resiliency in the 

medical device supply chain and to seek input on 

the new Resilient Supply Chain Program (RSCP). 

The RSCP aims to build upon a foundation of 

strong partnerships to improve supply chain

resiliency through proactive communication, 

collaboration, and engagement with patient 

advocates, health care providers, distributors, 

group purchasing organizations, manufacturers, 

as well as key component and material suppliers.

June 9, 2022 Webinar FDA Grand Rounds: 

Some Perspectives 

on Data Science and 

Coronaviruses (link)

To present perspectives, illustrated with recent 

COVID-19 experience and examples, on how in 

silico modelling and data science techniques could 

strengthen nonclinical (in vitro and animal) models 

for existing and emerging coronaviral diseases, 

including updates on some FDA-funded research.
57

Date Type of 

Event Event Name Purpose

June 14-15, 2022 Advisory 

Committee

VRBPAC (link) To discuss (Topic I) amending the EUA of the 

Moderna COVID-19 mRNA vaccine to include the 

administration of the primary series to children 

and adolescents 6 years through 17 years of age, 

and (Topic II) amending the EUA of the Moderna 

COVID-19 mRNA vaccine to include the administration of the primary series to infants and children 

6 months through 5 years of age, and amending 

the EUA of the Pfizer-BioNTech COVID-19 mRNA 

vaccine to include the administration of the primary 

series to infants and children 6 months through 4 

years of age.

June 28, 2022 Webinar FDA Drug Topics: 

Drug Shortages: Root 

Causes and Potential 

Solutions (link)

To provide a general overview of CDER’s Drug 

Shortages program, current shortage issues, 

and challenges.

June 28, 2022 Advisory 

Committee

VRBPAC (link) To discuss whether and how the SARS-CoV-2 

strain composition of COVID-19 vaccines should 

be modified.

July 11-13, 2022 Training 

course

Achieving Data 

Quality and Integrity in 

Clinical Trials Involving 

High-Consequence 

Pathogens (link)

To enable participants to learn about clinical 

research protocols for high-consequence 

pathogens, and help identify and mitigate barriers 

to data quality and integrity in domestic and 

international barrier environments involving 

MCMs. This annual course was presented by 

FDA and the University of Texas Medical Branch 

(UTMB), and held at the National Training, 

Simulation and Quarantine Center (TSQC) at 

University of Nebraska Medical Center/Nebraska 

Medicine, a National Ebola Training and 

Education Center (NETEC) facility.

July 14, 2022 Webinar FDA Grand Rounds: 

One Health at FDA: 

From Concept to 

Application (link)

To describe the One Health concept and how it 

applies to FDA’s regulatory mission and activities.

July 19-20, 2022 Public 

workshop

Office of Study 

Integrity and 

Surveillance (OSIS) 

Workshop 2022: 

CDER Inspections 

of Good Laboratory 

Practice, Animal Rule, 

and Bioavailability/

Bioequivalence Study 

Sites (link)

To describe the mission and vision of OSIS; 

identify the basic elements needed for a 

bioanalytical lab to successfully undergo an FDA 

inspection; and to provide an overview of compliance programs dealing with inspections of facilities that perform good laboratory practice (GLP), 

Animal Rule, in vivo clinical bioavailability (BA)- 

bioequivalence (BE), or in vivo analytical BA/

BE; and engage attendees to work through case 

studies representative of the above programs.
58

Date Type of 

Event Event Name Purpose

August 29-30, 2022 Public 

workshop

Gastrointestinal Acute 

Radiation Syndrome 

(GI-ARS) Workshop: 

Mechanisms, Models, 

Markers, and Medical 

Countermeasures

Co-sponsored by NIH, BARDA, and FDA for 

discussion of gastrointestinal radiation injury 

with respect to: clinical manifestations; animal 

models for efficacy studies; mechanisms and 

biomarkers; regulatory considerations for product 

development; and industry’s experience.

August 30, 2022 Public 

workshop

Drug Development 

Considerations for 

the Prevention of 

Healthcare-Associated 

Infections (link)

Co-sponsored by FDA and CDC to discuss 

topics including the current state of development 

of pathogen-directed products used to prevent 

health care-associated infections, and antimicrobial resistance threats as potential targets for 

decolonization and pathogen reduction.

September 13, 2022 Public 

workshop

Embracing The 

Future: Regulatory 

Considerations And 

Industry Perspectives 

On Advanced 

Manufacturing (link)

FDA’s India Office and the Drug Information 

Association (DIA) India Office hosted this 

workshop to discuss regulatory policies, guidance, 

and support for the adoption of advanced 

manufacturing technologies.

September 14, 2022 Webinar An Overview of 

Sentinel’s Publicly 

Available Analytics 

Tools 

To explore the resources available in Sentinel 

for individuals unfamiliar with Sentinel’s analytics 

tools and the Sentinel Common Data Model.

September 19, 2022 Public 

workshop

Increasing the 

Efficiency of Biosimilar 

Development 

Programs (link)

To discuss possible innovative ideas that have 

the potential to streamline and improve the 

efficiency of biosimilar development, with a focus 

on comparative clinical studies associated with 

biosimilar development programs.

September 20-22, 2022 Symposium 2022 CBER Science 

Symposium (link)

To discuss scientific topics related to the regulation of biologics and highlight science conducted 

at CBER by showcasing how scientific research 

informs regulatory decision making, and to provide 

a forum for developing collaborations within FDA 

and with external organizations.

September 21, 2022 Webinar Webinar on the Policy 

for Monkeypox Tests 

(link)

To inform stakeholders about the recently 

published final guidance, Policy for Monkeypox 

Tests to Address the Public Health Emergency, 

provide highlights of the final guidance, and 

answer questions from attendees.

September 22, 2022 Advisory 

Committee

VRBPAC (link) To discuss BLA #125739 from Rebiotix Inc. for a 

product, Rebyota (Fecal Microbiota, Live), with 

a requested indication to reduce the recurrence 

of Clostridioides difficile infection (CDI) in adults 

following antibiotic treatment for recurrent CDI.
59

Date Type of 

Event Event Name Purpose

September 27, 2022 Webinar FDA Drug Topics: 

Development and 

U.S. Regulation of 

Preventative Vaccines 

(link)

To provide an overview of the development and 

federal regulations for vaccines in the U.S., 

including key statutes that grant FDA authority to 

regulate vaccines, precipitating historical events, 

and current regulatory requirements for vaccine 

licensure and marketing approval.
60

APPENDIX 5: ACRONYMS

AI Artificial intelligence

AMDAC Antimicrobial Drugs Advisory 

Committee

AMMP Additive Manufacturing of 

Medical Products

AMQP Animal Model Qualification

Program

ANDA Abbreviated New Drug 

Application 

APHIS Animal and Plant Health 

Inspection Service (USDA)

ARS Acute radiation syndrome

ASPR Administration for Strategic 

Preparedness and Response 

(HHS)

BA Bioavailability

BAA Broad Agency Announcement

BARDA Biomedical Advanced Research 

and Development Authority

BE Bioequivalence

BLA Biologics License Application

BSL Biosafety level

CAD Computer-aided design

CADe Computer-assisted detection

CANA Convulsant antidote for nerve 

agent

CARES Act Coronavirus Aid, Relief, and 

Economic Security Act

CBRN Chemical, biological, radiological, 

and nuclear 

CBER FDA Center for Biologics 

Evaluation and Research 

CDC U.S. Centers for Disease Control 

and Prevention

CDER FDA Center for Drug Evaluation 

and Research 

CDI Clostridioides difficile infection

CDRH FDA Center for Devices and 

Radiological Health 

CDS Clinical decision support

CEPI Coalition for Epidemic 

Preparedness Innovations

CERSI Center of Excellence in Regulatory 

Science and Innovation

CFR Code of Federal Regulations

CHLA Children’s Hospital Los Angeles

CITC Clinical Investigator Training 

Course

CLIA Clinical Laboratory Improvement 

Amendments

CMS Centers for Medicare and 

Medicaid Services 

COVID-19 Coronavirus disease 2019 

(caused by SARS-CoV-2)

CSIRO Commonwealth Scientific and 

Industrial Research 

Organization (Australia)

CTAP Coronavirus Treatment 

Acceleration Program

Cures Act 21st Century Cures Act

DARPA Defense Advanced Research 

Projects Agency

DIA Drug Information Association

DNA Deoxyribonucleic acid

DoD U.S. Department of Defense

DRC Democratic Republic of the Congo

DSCSA Drug Supply Chain Security Act

DTRA Defense Threat Reduction Agency

EA Expanded Access

ECMO Extracorporeal membrane 

oxygenation

EIND Emergency Investigational New 

Drug application

EUA Emergency Use Authorization

EVD Ebola virus disease

FAQ Frequently asked questions

FARS Focus Areas of Regulatory Science

FD&C Act Federal Food, Drug, and 

Cosmetic Act 

FDA U.S. Food and Drug 

Administration

FDA-ARGOS FDA Database for Regulatory 

Grade Microbial Sequences 

FIND Foundation for Innovative 

New Diagnostics

FTE Full-time equivalent
61

FY Fiscal year

GCP Good clinical practice

GHSA Global Health Security Agenda

GHSI Global Health Security Initiative

GI-ARS Gastrointestinal acute radiation 

syndrome

GloPID-R Global Research Collaboration 

for Infectious Diseases 

Preparedness

GLP Good laboratory practice

HCT/P Human cells, tissues, and cellular 

and tissue-based products 

HDE Humanitarian Device Exemption

HHS U.S. Department of Health 

and Human Services

IBx Innovation and Industrial 

Base Expansion (HHS/ASPR 

program)

ICMRA International Coalition of 

Medicines Regulatory 

Authorities

ICU Intensive care unit

IDE Investigational Device Exemption

IND Investigational New Drug

INSPIRE Innovative Support for Patients 

with SARS-CoV-2 Infections 

(a CDC-funded study)

IPTW Inverse Probability of 

Treatment Weighting

I-TEAM Innovative Technologies and 

Advanced Manufacturing 

IV Intravenous

IVD In vitro diagnostic

JEE Joint External Evaluation

JPEO-CBRND Joint Program Executive Office 

for Chemical, Biological, 

Radiological and Nuclear 

Defense (DoD)

kg Kilogram

LDT Laboratory developed test

LLNL Lawrence Livermore National 

Laboratory

LRN Laboratory Response Network 

(CDC)

mAb Monoclonal antibody

MCM Medical countermeasure

MCMi FDA Medical Countermeasures 

Initiative

MDDS Medical device data system

MERS-CoV Middle East Respiratory 

Syndrome coronavirus

mg Milligram

MHRA Medicines and Healthcare 

products Regulatory Agency

(UK)

mL Milliliter

MMA Mobile medical application

MOU Memorandum of Understanding

mpox Disease caused by the 

monkeypox virus

MPS Microphysiological systems

MRI Magnetic resonance image

NACCHO National Association of County 

and City Health Officials

NASA National Aeronautics and 

Space Administration

NASEM-HMD National Academies of Sciences, 

Engineering, and Medicine, 

Health and Medicine Division

NBBI National Biotechnology and 

Biomanufacturing Initiative

NCBI National Center for Biotechnology 

Information

NDA New Drug Application

NETCCN National Emergency Telecritical 

Care Network 

NEST National Evaluation System 

for health Technology

NETEC National Ebola Training and 

Education Center

NGDS Next-Generation Diagnostic 

System (DoD)

NGO Non-governmental organization

NGS Next-generation sequencing

NHP Nonhuman primate

NIAID National Institute of Allergy and 

Infectious Diseases (NIH)

NIH U.S. National Institutes of Health

NIST U.S. National Institute of 

Standards and Technology 

NPS Nasopharyngeal swab

NS Nasal swab
62

NSTC National Science and 

Technology Council

OCET FDA Office of Counterterrorism 

and Emerging Threats 

OCS FDA Office of the Chief Scientist

ONC Office of the National Coordinator 

for Health Information 

Technology (HHS)

OSIS Office of Study Integrity 

and Surveillance

OSTP Office of Science and Technology 

Policy (White House)

OTC Over-the-counter

PACS Post-acute COVID syndrome 

(medical term for long 

COVID-19, also sometimes 

referred to as post-acute 

sequelae of COVID-19, 

or PASC)

PAHPAIA Pandemic and All-Hazards 

Preparedness and Advancing 

Innovation Act of 2019

PAHPRA Pandemic and All-Hazards 

Preparedness Reauthorization 

Act of 2013

PASC Post-acute sequelae of COVID-19 

(also see PACS)

PBMC Peripheral blood mononuclear cell

PCR Polymerase chain reaction

PDUFA Prescription Drug User Fee Act

PHEMCE Public Health Emergency Medical 

Countermeasures Enterprise 

PHS Act Public Health Service Act

PMA Premarket Approval

PPE Personal protective equipment 

PRV Priority review voucher

rad/nuc Radiological/nuclear

RADx Rapid Acceleration of Diagnostics 

program (NIH)

RECOVER Researching COVID to Enhance 

Recovery (NIH)

REdI Regulatory Education for Industry

REMM Radiation Emergency Medical 

Management

REMS Risk Evaluation and Mitigation 

Strategies

RMP Regulatory Management Plan

RNA Ribonucleic acid

RSCP Resilient Supply Chain Program 

(may also be referred to as 

RSCSPP, the Resilient Supply 

Chain and Shortages Prevention Program)

RSV Respiratory syncytial virus

SARS-CoV-2 Severe Acute Respiratory 

Syndrome Coronavirus 2

SHIELD Systemic Harmonization and 

Interoperability Enhancement 

for Laboratory Data

SLEP Shelf-Life Extension Program

SLTT State, local, tribal and territorial

SNS Strategic National Stockpile

SPA Special Protocol Assessment

SUDV Sudan ebolavirus

TATRC Telemedicine and Advanced 

Technology Research Center 

(DoD)

TBI Traumatic brain injury

TSQC Training, Simulation and 

Quarantine Center

TTFED Tri-Agency Task Force for 

Emergency Diagnostics

UKHSA UK Health Security Agency 

U.S. United States

USAMRDC U.S. Army Medical Research and 

Development Command

USDA U.S. Department of Agriculture

USG United States government

UTMB University of Texas 

Medical Branch

VA U.S. Department of 

Veterans Affairs

VHA Veterans Health Administration

VRBPAC Vaccines and Related Biological 

Products Advisory Committee

WHO World Health Organization
63

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