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  					Medical countermeasure and public health emergency news and events from FDA and partners
	
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              News & events text shown on typewriterOn this page: MCM-related news | Events | COVID-19 resources | Funding opportunities | Connect with us

Featured news and events

**COVID-19 updates from FDA**
	**June 16, 2023:**Updated COVID-19 Vaccines for Use in the United States Beginning in Fall 2023
	**June 14, 2023:**MCMi email - Join us at the FDA Science Forum today for MCM sessions | Update on antimicrobial resistance (if you missed it, recordingof the MCM session)
	**June 6, 2023:**FDA Announces Additional Steps to Modernize Clinical Trials
	**May 25, 2023:** FDA Approves First Oral Antiviral for Treatment of COVID-19 in Adults
	**MCMi Fiscal Year 2022 Program Update** - FDA and our partners work every day to help facilitate development of and access to safe, effective medical countermeasures to counter emerging threats. Learn more about the steps we're taking to protect national health and security in this report. View the PDF (1.5 MB).MCM-related news from FDA and our partners (by date)
	**June 16, 2023:**Updated COVID-19 Vaccines for Use in the United States Beginning in Fall 2023 - FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on June 15, 2023, to discuss and make recommendations for SARS-CoV-2 strain(s) for updated COVID-19 vaccines for use in the United States beginning in the fall of 2023.For the 2023-2024 formulation of the COVID-19 vaccines for use in the U.S. beginning in the fall of 2023, the committee unanimously voted that the vaccine composition be updated to a monovalent COVID-19 vaccine with an XBB-lineage of the Omicron variant. Following discussion of the evidence, the committee expressed a preference for XBB.1.5. *Also see: Recommendation for the 2023-2024 Formula of COVID-19 vaccines in the U.S. (PDF, 91 KB)*
	**June 14, 2023:**MCMi email - Join us at the FDA Science Forum today for MCM sessions | Update on antimicrobial resistance
	**June 12, 2023:**Antimicrobial resistance update - FDA announcedthat Guidance for Industry (GFI) #263 has been fully implemented and all affected animal drug sponsors opted to either voluntarily change the approved marketing status of certain medically important antimicrobial drugs for animals from over-the-counter (OTC) to prescription (Rx) or to voluntarily withdraw approval of their affected OTC animal drug applications. Animal owners and caretakers will still have access to appropriate antimicrobials to address animal health issues by consulting with a licensed veterinarian. The successful implementation of GFI #263 is an encouraging demonstration of the commitment of animal drug sponsors and veterinarians to support the judicious use of antimicrobials in animals.
	**June 7, 2023:**MCMi email - 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
	**June 6, 2023:** FDA Permits Marketing of First COVID-19 At-Home Test Using Traditional Premarket Review Process - FDA granted marketing authorization for the Cue COVID-19 Molecular Test. The product is a molecular nucleic acid amplification test (NAAT) that is intended to detect genetic material from SARS-CoV-2 virus present in nasal swabs from adults with signs and symptoms of upper respiratory infection. This test is the first at-home over-the-counter (OTC) test for COVID-19 to be granted marketing authorization using a traditional premarket review pathway and the first ever at-home test authorized using a traditional premarket review pathway for any respiratory illness.
	**June 6, 2023:**FDA Announces Additional Steps to Modernize Clinical Trials -****FDA announced availability of a draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernizing the design and conduct of clinical trials, making them more agile without compromising data integrity or participant protections. The updates are intended to help pave the way for more efficient clinical trials to facilitate the development of medical products. FDA is requesting feedback on the draft recommendations and how they should be applied to increasingly diverse trial types and data sources. Submit comments by **September 6, 2023**.
	**June 1, 2023:**On May 22, 2023, Janssen Biotech, Inc. requested the voluntary withdrawal of the EUA of the Janssen COVID-19 Vaccine. Janssen Biotech, Inc. informed the FDA that the last lots of the vaccine purchased by the U.S. Government have expired, there is no demand for new lots of the vaccine in the U.S., and they do not intend to update the strain composition of this vaccine to address emerging variants. On June 1, 2023, FDA revoked the EUA (PDF, 100KB) for this vaccine. *Also see: Emergency Use Authorization--Archived Information*
	**May 31, 2023:**FDA approved a second vaccine for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in individuals 60 years and older
	**May 31, 2023:**Hurricane Emergency Preparedness and Medical Devices: Recommendations for Health Care Providers, Device Manufacturers and Distributors (new web page)
	**May 31, 2023:** MCMi email - FDA approves first oral antiviral for treatment of COVID-19 in adults*View more news in the MCMi News Archive*

Upcoming events
	**June 20, 2023:**Decentralized Clinical Trials (DCT) Draft Guidance webinar (3:00 - 4:00 p.m. ET) - As part of FDA’s efforts to be responsive to the rapidly evolving clinical trial landscape and clarify the Agency’s recommendations on the conduct of DCTs, FDA will provide an overview of the draft guidance, Decentralized Clinical Trials for Drugs,Biological Products, and Devices.
	**September 26-27, 2023:**FDA/PQRI Workshop on the Regulatory Framework for the Utilization of Artificial Intelligence in Pharmaceutical Manufacturing (virtual) - This workshop, hosted by FDA and the Product Quality Research Institute (PQRI), aims to facilitate interaction among AI stakeholders on critical areas for development, implementation, and regulatory consideration including uses in process development and control, operation of Pharmaceutical Quality Systems, lifecycle approaches, and Current Good Manufacturing Practice. Registration will open in Summer 2023.
	**September 28-29, 2023:**Complex *In Vitro* Model (CIVM) Qualification Framework Public Workshop (Bethesda, MD) - Hosted by the Critical Path Institute (C-Path) Predictive Safety Testing Consortium, with stakeholders from FDA, academia, model developers, and the pharmaceutical industry, this workshop aims to form a consensus on model standards and features to improve performance of liver CIVMs as a tool for drug development and regulatory assessment. The meeting will also include sessions to discuss system optimization and cell sourcing, model validation and performance, and defining contexts of use to address unmet needs in regulatory decision making. Please register in advance.*Previous events: MCMi Events Archive*

COVID-19 resources from FDA
	**General information**

COVID.gov - Find COVID-19 guidance for your community (a U.S. government website)
	Coronavirus Disease 2019 (COVID-19)
	Multilingual COVID-19 Resources
	COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders
	FAQs: What happens to EUAs when a public health emergency ends?**Vaccines**

COVID-19 Vaccines
	Why should I get the updated COVID-19 vaccine now?
	More Video Frequently Asked Questions: Just a Minute! videos with Dr. Peter Marks on YouTube
	Vaccine Development – 101
	Emergency Use Authorization for Vaccines Explained
	Vaccine EUA Questions and Answers for Stakeholders
	The Path for a COVID-19 Vaccine from Research to Emergency Use Authorization(PDF, 723 KB)**Therapeutics**

Know Your Treatment Options for COVID-19
	An Update and Behind the Scenes: FDA’s Coronavirus Treatment Acceleration Program
	CDER Scientific Review Documents Supporting Emergency Use Authorizations for Drug and Biological Therapeutic Products | COVID-19
	FDA Updates on Paxlovid for Health Care Providers (May 2022)
	Why You Should Not Use Ivermectin to Treat or Prevent COVID-19**Testing**

FDA encourages you to voluntarily and anonymously report your positive or negative test results every time you use an at-home COVID-19 test. You can report your test result by going to MakeMyTestCount.org or by using an app or other digital option for self-reporting that may be included with your test.
	Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results
	Coronavirus Testing Basics
	At-Home OTC COVID-19 Diagnostic Tests
	Search for No-Cost COVID-19 Testing​ (CDC)
	A Closer Look at COVID-19 Diagnostic Testing(for health care providers, test purchasers, and public health staff)
	SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests
	Screening for COVID-19: Deciding Which Test to Use When Establishing Testing Programs
	In Vitro Diagnostics EUAs**Regulatory science**

FDA-ARGOS SARS-CoV-2 Reference Grade Sequence Data Now Available
	3D Printing in FDA’s Rapid Response to COVID-19
	Investing in Advanced Manufacturing to Support Public Health Preparedness
	Wastewater Surveillance for SARS-CoV-2 Variants
	Extramural research, including projects supporting the COVID-19 response

Funding opportunities and challenge information
	**FDA funding opportunity**- Extramural MCM regulatory science is primarily funded through a Broad Agency Announcement (BAA) for research and development to support regulatory science and innovation.****Check the FDA BAA Day (December 6, 2022) page for event recordings to learn more about the FY 2023 BAA, and how to apply, including BAA Q&A. For funding consideration in FY 2023, white papers are due by 5:00 p.m. EST, January 23, 2023**.***Learn more: Extramural Research*

**April 2023:** RFI open to solicit ideas for ARPA-H, FDA collaboration - The Advanced Research Projects Agency for Health (ARPA-H) is seeking unique and creative ideas on how to best collaborate with the Food and Drug Administration to encourage and incentivize public-private partnerships in the health ecosystem, with the goal of accelerating better health outcomes for everyone. Interested persons and organizations are invited to submit comments on or before **5:00 p.m. ET on May 30, 2023**. Early submissions are encouraged as materials will be reviewed on a rolling basis.

Connect with us

Follow Us On Twitter **Follow @FDA_MCMi on Twitter**

MCMi email updates **View previous editions of the MCMi email newsletter**

For more information

MCMi

MCMi News Archive - MCMi news from 2010 to the present
	MCMi Events Archive - MCMi events from 2010 to the present
	Publications and Reports - including annual MCMi program updatesEmergency use

Emergency Use Authorization****(all current EUAs, including information about amendments)
	Expiration Dating Extension****(including the Shelf Life Extension Program, and product-specific information)
	MCM Emergency Use Authorities (information about, including EUA)
	Emergency Dispensing Orders and Emergency Use Instructions (EUI)Guidance and industry information

MCM-Related Guidance by Date****(including comment deadlines, where applicable)
	Guidance and Other Information of Special Interest to MCM Stakeholders (by topic)
	Search for FDA Guidance DocumentsPublic health emergency response updates and MCM-related issues

FDA Mpox Response
	Antimicrobial resistance information from FDA
	Ebola Preparedness and Response
	FDA/DoD Collaborations
	Preparedness Information for Consumers
	More topic-specific pages, including radiological and nuclear emergency preparedness, smallpox preparedness, pediatric MCMs, and MCM monitoring and assessmentProduct shortages and availability

Drug Shortages
	CBER-Regulated Products: Shortages and Discontinuations (vaccines, blood, biologics)
	Drug Shortages Database
	How to report a product shortage or supply issue to FDAMore FDA news and events

FDA Newsroom - press announcements, fast facts, speeches, and more
	FDA Voices - perspectives from FDA expertsHHS

Medicalcountermeasures.gov
	Administration for Strategic Preparedness and Response

                                                                                  Content current as of:
      11/13/2023
              
              
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