MCM News and Events

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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).

• Updates on Highly Pathogenic Avian Influenza (HPAI) in dairy cows

• 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)

• COVID-19 updates from FDA

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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

• 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)

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)

• SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests

• In Vitro Diagnostics EUAs

Regulatory science

• 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

Extramural MCM regulatory science is primarily funded through a Broad Agency Announcement (BAA) for research and development to support regulatory science and innovation. Learn more: Extramural Research

Connect with us

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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

HHS

• Medicalcountermeasures.gov
• Administration for Strategic Preparedness and Response