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              Hand holding smartphone with new email notification, with computer in backgroundFDA’s Medical Countermeasures Initiative (MCMi) is an agency-wide initiative to coordinate medical countermeasure development, preparedness and response to help protect the United States from chemical, biological, radiological, nuclear, and emerging infectious disease threats.

Stay up-to-date on news, events, reports and more from MCMi and FDA partners:

**Subscribe: enter your email in the Subscribe box at the bottom of this page to receive MCMi email updates.**
	To subscribe to other FDA emails, visit our subscription management center. (To ensure that you receive MCMi email updates, the Emergency Preparedness and Response - FDA Medical Countermeasures Initiative (MCMi) News should be checked).
	Bookmark the MCMi news pagePrevious editions

2023 | 2022 | 2021 and earlier

*Note that links in previous editions may no longer be active.*

2023

September 20, 2023: FDA Takes Action on Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants
	August 31, 2023: FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants
	August 18, 2023: Registration open for annual training course on achieving data quality and integrity in clinical trials involving high-consequence pathogens
	July 27, 2023: FDA Approves Vaccine for Post-Exposure Prophylaxis of Anthrax
	July 13, 2023: FDA Revises Two Guidances to Extend Enforcement Discretion Policies
	June 30, 2023: FDA Update on Proposal for a Unified Human Foods Program
	June 14, 2023: Join us at the FDA Science Forum today for MCM sessions | Update on antimicrobial resistance
	June 7, 2023: FDA permits marketing of first COVID-19 at-home test using traditional premarket review process | Join us for the FDA Science Forum June 13-14
	May 31, 2023: FDA approves first oral antiviral for treatment of COVID-19 in adults
	May 24, 2023: Improving medical product manufacturing capacity and flexibility: new VHA & FDA collaboration
	May 17, 2023: COVID-19 end of PHE reminders | AI discussion paper
	May 10, 2023: End of COVID-19 public health emergency updates | FDA approves first RSV vaccine
	May 3, 2023: Updates on antimicrobial resistance, device cybersecurity, COVID-19 vaccines and tests + more
	April 26, 2023: Join FDA and BARDA April 27 for a workshop: Recombinant Protein-Based COVID-19 Vaccines
	April 19, 2023: FDA authorizes changes to simplify use of bivalent mRNA COVID-19 vaccines | New EUA for COVID-19 at-home test
	April 5, 2023: FDA authorizes a new COVID-19 treatment for certain hospitalized adults | Last chance to pre-register for data quality in BSL-4 labs course
	March 29, 2023: Register now to share your long COVID experience with FDA | Transition plans for COVID-19 related medical devices
	March 22, 2023: COVID-19 and mpox testing updates | Data standards for Animal Rule studies
	March 15, 2023: COVID-19-related guidance documents update | FDA permits marketing of first COVID-19 antigen test using traditional premarket review process
	March 8, 2023: Advanced manufacturing updates | Register now for March and April events
	March 1, 2023: FDA authorizes first over-the-counter at-home test to detect both influenza and COVID-19 viruses
	February 22, 2023: COVID-19 EUA updates | Join us for a March 9 Grand Rounds on microphysiological systems and Zika research
	February 15, 2023: New report: Learn how FDA supports development of & access to medical countermeasures
	February 8, 2023: Report your COVID-19 at-home test results | Now hiring: Regulatory Counsel
	February 1, 2023: COVID-19 therapeutics update: Evusheld not currently authorized in U.S. | Watch out for illegally sold mpox products
	January 25, 2023: Developers of drug and biological products for mpox: new draft guidance | Jan. 26 VRBPAC viewing info.
	January 18, 2023: Regulatory science funding deadline reminder | COVID-19 and mpox updates from FDA
	January 11, 2023: COVID-19 variant updates | Pediatric disease modeling for long COVID
	January 4, 2023: FDA approves treatment for certain hospitalized adults with COVID-192022

December 21, 2022: Vaccine advisory committee meeting on future of COVID-19 vaccines | Understanding at-home OTC COVID-19 antigen diagnostic test results
	December 14, 2022: FDA authorizes updated (bivalent) COVID-19 vaccines for children down to 6 months of age | Join EMA & FDA for a Dec. 15 mAb workshop
	December 7, 2022: FDA approves first fecal microbiota product | COVID-19 therapeutic EUA updates
	November 30, 2022: FDA authorizes a COVID-19 and flu point-of-care test | FDA & NIST advanced manufacturing collaboration
	November 22, 2022: Advanced manufacturing updates | Fast facts for health care providers: bivalent COVID-19 vaccines
	November 16, 2022: New funding opportunities | COVID-19 and monkeypox response updates | Modeling & simulation at FDA
	November 9, 2022: Why should I get the updated COVID-19 vaccine now? + COVID-19 therapeutics updates from FDA
	November 2, 2022: Public health emergency response updates from FDA, including COVID-19 and monkeypox
	October 26, 2022: COVID-19 vaccine and therapeutics updates | Monkeypox LDT list
	October 19, 2022: Public health emergency response news from FDA | Regulatory science & funding updates
	October 12, 2022: FDA authorizes bivalent COVID-19 vaccine boosters in younger age groups | First commercial test kit for detection of monkeypox
	October 5, 2022: Latest updates about Evusheld for PrEP for COVID-19
	September 28, 2022: FDA updates COVID-19 test policy | New printable COVID-19 vaccine wall charts including bivalent boosters
	September 21, 2022: New webinar series for monkeypox test developers starts today | Save the date for BAA Industry Day + more news & events
	September 14, 2022: FDA takes significant action to help expand access to monkeypox testing | COVID-19 response updates from FDA
	September 7, 2022:What is a bivalent vaccine? +more COVID-19 booster info, and September/October events
	August 31, 2022: FDA authorizes Moderna, Pfizer-BioNTech bivalent COVID-19 vaccines for use as a booster dose | Media call today at 10:45 a.m. ET
	August 24, 2022: Check your COVID-19 test expiration dates | Monkeypox response updates from FDA
	August 17, 2022: COVID-19 and monkeypox response updates from FDA | Monkeypox vaccine fact sheet in multiple languages
	August 10, 2022: Public health emergency response updates from FDA: COVID-19 and monkeypox updates
	July 20, 2022: COVID-19 response updates from FDA | Monkeypox testing safety communication
	July 13, 2022: FDA authorizes pharmacists to prescribe Paxlovid | Advanced manufacturing job openings
	July 6, 2022: COVID-19 vaccine and therapeutic updates | FDA seeking consumer representatives for advisory committees
	June 29, 2022: Updates from FDA on COVID-19 medical countermeasures, monkeypox testing, advanced manufacturing, and more
	June 22, 2022: FDA authorizes Moderna and Pfizer-BioNTech COVID-19 vaccines for children down to 6 months of age
	June 15, 2022: First COVID-19 test to identify specific SARS-CoV-2 lineages authorized
	June 8, 2022: COVID-19 updates from FDA | Collaborating to enhance testing capacity during public health emergencies
	June 1, 2022: June event updates: vaccine advisory committees, register now for July course on clinical trials involving high-consequence pathogens
	May 25, 2022: Updated vaccine advisory committee dates | Know your treatment options for COVID-19
	May 18, 2022: FDA expands eligibility for Pfizer-BioNTech COVID-19 Vaccine booster dose to children 5 through 11 years
	May 11, 2022: COVID-19 response updates from FDA: vaccines, tests, treatments, regulatory science & more
	May 4, 2022: COVID-19 at-home test updates: expiration date extensions, watch out for counterfeit tests
	April 27, 2022: FDA approves first COVID-19 treatment for young children
	April 13, 2022: FDA authorizes more OTC at-home COVID-19 tests | Shelf life extension for a COVID-19 vaccine
	April 6, 2022: EUA updates and FAQs | Watch live today: VRBPAC meeting
	March 30, 2022: FDA authorizes second booster dose of two COVID-19 vaccines for ages 50+ and immunocompromised individuals
	March 23, 2022: COVID-19 test safety information | MCMi job alert: Regulatory counsel
	March 16, 2022: New Medical Countermeasures Initiative report and COVID-19 response infographic
	March 9, 2022: More video FAQs on COVID-19 vaccines | Regulatory science update: 3D tissue chips
	March 2, 2022:COVID-19 testing updates | Revisions to COVID-19 therapeutic EUAs
	February 23, 2022: New resource on at-home OTC COVID-19 tests | MCMi job alert: Interdisciplinary scientist
	February 16, 2022: FDA authorizes new monoclonal antibody that retains activity against omicron | Feb. 22 webinar on transition plans for COVID-19 medical devices
	February 9, 2022: COVID-19 test safety alert | Using real-world evidence to advance COVID-19 medical countermeasures
	February 2, 2022: FDA approves 2nd COVID-19 vaccine | Feb. 15 advisory committee scheduled
	January 26, 2022: FDA takes actions to expand use of treatment for outpatients with mild-to-moderate COVID-19 | At-home diagnostic test updates
	January 19, 2022: Video FAQs about COVID-19 vaccines | Apply by Jan. 21 for regulatory science funding
	January 12, 2022: COVID-19 response updates: tests, vaccines, events, and more
	January 5, 2022: Boosters are now authorized for people 12 years of age and olderNewsletter archives

For MCMi newsletters from 2018-2021, please visit this archive page
	For MCMi newsletters from 2017, please visit this archive page
	For MCMi newsletters from 2014-2016, please visit this archive page

                                                                                  Content current as of:
      09/21/2023
              
              
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