MCMi News and Events
Medical countermeasure and public health emergency news and events from FDA and partners
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Featured news and events
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It's not too late to join the 2023 FDA Science Forum! Today's (June 14) sessions start at 9:00 a.m. ET, with topics including medical countermeasures, infectious diseases, and pathogen reduction technologies. Livestream the MCM session (no registration required).
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June 14, 2023: MCMi email - Join us at the FDA Science Forum today for MCM sessions | Update on antimicrobial resistance
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June 6, 2023: FDA Announces Additional Steps to Modernize Clinical Trials
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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
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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).
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June 14, 2023: MCMi email - Join us at the FDA Science Forum today for MCM sessions | Update on antimicrobial resistance
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June 12, 2023: Antimicrobial resistance update - FDA announced that 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.
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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
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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
- May 25, 2023: FDA Approves First Oral Antiviral for Treatment of COVID-19 in Adults - FDA approved the oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is the fourth drug—and first oral antiviral pill—approved by the FDA to treat COVID-19 in adults. Paxlovid manufactured and packaged under the EUA and distributed by HHS will continue to be available to ensure continued access for adults, as well as treatment of eligible children ages 12-18 who are not covered by today’s approval. Paxlovid is not approved or authorized for use as a pre-exposure or post-exposure prophylaxis for prevention of COVID-19. Also see these updated resources: Paxlovid Patient Eligibility Screening Checklist Tool for Prescribers (PDF, 323 KB), Frequently Asked Questions on the EUA for Paxlovid for Treatment of COVID-19 (PDF, 349 KB), and Fact Sheet for Healthcare Providers: EUA for Paxlovid (PDF, 724 KB), (new) approved product label (PDF, 5.1 MB)
- May 24, 2023: MCMi email - Improving medical product manufacturing capacity and flexibility: new VHA & FDA collaboration
- May 23, 2023: FDA Approves New Treatment for Pneumonia Caused by Certain Difficult-to-Treat Bacteria - FDA approved Xacduro (sulbactam for injection; durlobactam for injection), a new treatment for hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible strains of bacteria called Acinetobacter baumannii-calcoaceticus complex, for patients 18 years of age and older. According to the World Health Organization, Acinetobacter species top the list of critical bacterial pathogens that pose the greatest threat to human health, highlighting the high level of need for additional treatment options amid growing global resistance to antimicrobial medicines.
- May 22, 2023: FDA and the Veterans Health Administration announced a new collaboration to jointly develop emergency preparedness and response tools and protocols intended to help increase medical product manufacturing capacity and flexibility, and improve resilience of domestic supply chains during emergencies, shortages, and pandemics. A new Memorandum of Understanding (MOU) will help facilitate the development of requirements for trusted networks needed to enable the use of distributed manufacturing and digital stockpiles, which could ultimately enable veterans and civilians to more rapidly access innovative medical products to support their care. Learn more, including descriptions of these advanced manufacturing approaches.
- May 17, 2023: FDA issues two draft guidances for industry to support the approval of pediatric drug products - FDA issued two draft guidances for industry entitled, Pediatric Drug Development: Regulatory Considerations – Complying with PREA and Qualifying for Pediatric Exclusivity Under the BPCA and Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations. Both guidances, once finalized, will provide recommendations to support the assessment of pediatric drugs, biological products, and vaccines under the Pediatric Research Equity Act (PREA) and/or the Best Pharmaceuticals for Children Act (BPCA). The guidance documents revise and replace the draft guidance for industry How to Comply with the Pediatric Research Equity Act. Comments on both draft guidances are due by July 17, 2023.
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May 17, 2023: MCMi email - COVID-19 end of PHE reminders | AI discussion paper
View more news in the MCMi News Archive
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June 13-14, 2023: 2023 FDA Science Forum (virtual) - Topic areas include medical countermeasures, infectious disease and pathogen reduction technologies, and product development and manufacturing, including advanced manufacturing. See the agenda, and register now to attend, and receive post-event information. Don't miss the 200+ posters!
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June 15, 2023: Vaccines and Related Biological Products Advisory Committee meeting (virtual) - The committee will meet in open session to discuss and make recommendations on the selection of strain(s) to be included in the periodic updated COVID-19 vaccines for the 2023-2024 vaccination campaign.
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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.
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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.
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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
General information
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COVID.gov - Find COVID-19 guidance for your community (a U.S. government website)
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COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders
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FAQs: What happens to EUAs when a public health emergency ends?
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
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The Path for a COVID-19 Vaccine from Research to Emergency Use Authorization (PDF, 723 KB)
Therapeutics
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An Update and Behind the Scenes: FDA’s Coronavirus Treatment Acceleration Program
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FDA Updates on Paxlovid for Health Care Providers (May 2022)
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Why You Should Not Use Ivermectin to Treat or Prevent COVID-19
Testing
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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.
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Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results
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A Closer Look at COVID-19 Diagnostic Testing (for health care providers, test purchasers, and public health staff)
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Screening for COVID-19: Deciding Which Test to Use When Establishing Testing Programs
Regulatory science
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FDA-ARGOS SARS-CoV-2 Reference Grade Sequence Data Now Available
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Investing in Advanced Manufacturing to Support Public Health Preparedness
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Extramural research, including projects supporting the COVID-19 response
- 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
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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 updates
Emergency use
- Emergency Use Authorization (all current EUAs, including information about amendments)
- Expiration Dating Extension (including the Shelf Life Extension Program, and product-specific information)
- Emergency Use Authorizations (devices)
- 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 Documents
Public 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 assessment
Product 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 FDA
More FDA news and events
- FDA Newsroom - press announcements, fast facts, speeches, and more
- FDA Voices - perspectives from FDA experts