MCMi News and Events
Medical countermeasure and public health emergency news and events from FDA and partners
On this page: Featured | COVID-19 resources | Funding opportunities | Connect with us
Featured news and events
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MCMi Fiscal Year 2023 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 (1.8 MB).
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Updates on Highly Pathogenic Avian Influenza (HPAI) in dairy cows
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Influenza Diagnostic Tests - In response to requests from the public, FDA is providing a list of in vitro diagnostic tests that have FDA 510(k) clearance, or granted de novo request, or are authorized for emergency use (EUA), for the detection of influenza in certain specimens from humans. Most tests listed on this page for the detection of seasonal influenza may be capable of detecting influenza A/H5N1, which is a subtype of influenza A. However, only tests specifically designed for subtyping will be able to determine if the person has seasonal flu, or influenza A/H5. (May 2024)
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Join us July 30 - August 1, 2024 (Omaha, Nebraska or virtual) for a training course: Achieving Data Quality and Integrity in Clinical Trials Involving High-Consequence Pathogens. Pre-register by June 30, 2024 to attend in-person, or by July 12, 2024 to attend virtually.
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)
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
Connect with us
For more information
Reports
- 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)
- MCM Emergency Use Authorities (information about, including EUA)
- Emergency Dispensing Orders and Emergency Use Instructions (EUI)
Guidance and industry information
- 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
- Medical Device Supply Chain and Shortages
- 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