Featured news and events
Coronavirus Disease 2019 (COVID-19) updates from FDA, including the latest news, FAQs, and more
Register now for the June 14-18, 2021 virtual training course: Achieving Data Quality and Integrity in Maximum Containment Laboratories - Registration closes May 7, 2021.
MCMi Fiscal Year 2019 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 (1.3 MB).
- April 20, 2021: FDA Announces New Streamlined Approach to Add Pooled Serial Screening Claims to Certain Authorized Tests for Use in Serial Testing Programs
- April 16, 2021: FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab - FDA revoked the EUA that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients. Based on its ongoing analysis of emerging scientific data, specifically the sustained increase of SARS-CoV-2 viral variants that are resistant to bamlanivimab alone resulting in the increased risk for treatment failure, the FDA has determined that the known and potential benefits of bamlanivimab, when administered alone, no longer outweigh the known and potential risks for its authorized use. Therefore, the agency determined that the criteria for issuance of an authorization are no longer met and has revoked the EUA.
- April 14, 2021: FDA Provides Guidance on Remote Interactive Evaluations for Oversight of Drug Facilities During COVID-19
- April 14, 2021: MCMi email - Ensuring the safety and quality of COVID-19 vaccines | Registration open for training: Achieving Data Quality & Integrity in Maximum Containment Laboratories
- April 13, 2021: Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine
- April 12, 2021: Vaccine Ready: Addressing COVID-19 Health Disparities among Racial and Ethnic Minority Communities - also see the #VaccineReady Social Media Toolkit with resources in English and Spanish
- April 6, 2021: FDA Issues Emergency Use Authorization for the Symbiotica COVID-19 Self-Collected Antibody Test System
- April 2, 2021: FDA In Brief: FDA Provides Update on COVID-19 Pandemic Recovery and Preparedness Plan Initiative
- April 1, 2021: FDA Makes Two Revisions to Moderna COVID-19 Vaccine Emergency Use Authorization to Help Increase the Number of Vaccine Doses Available
- March 31, 2021: FDA Continues to Advance Over-the-Counter and Other Screening Test Development - FDA authorized several tests for over-the-counter (OTC) use without a prescription when used for serial screening.
- March 2021: FDA's Center for Devices and Radiological Health (CDRH) reorganized the SARS-CoV-2 In Vitro Diagnostics EUAs content on FDA.gov to help make it easier to find specific categories of EUAs and related information. With this update, new web pages have been created for these EUA types: Molecular Diagnostic Tests for SARS-CoV-2; Antigen Diagnostic Tests for SARS-CoV-2; Serology and Other Adaptive Immune Response Tests for SARS-CoV-2; IVDs for Management of COVID-19 Patients
- March 31, 2021: MCMi email - Learn more about COVID-19 vaccines | Emergency Use Authorization (EUA) updates
- March 30, 2021: SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests - FDA posted a new web page for clinical laboratory staff and health care providers about the impact of viral mutations on COVID-19 molecular, antigen, and serology tests. The FDA will update this page as significant new information becomes available.
- March 24, 2021: Consumer Update - Learn More About COVID-19 Vaccines
- March 24, 2021: From HHS/ASPR - Update on COVID-19 variants and impact on bamlanivimab distribution
- March 24, 2021: MCMi email - How you can help stop COVID-19
- March 23, 2021: Center for Drug Evaluation and Research Response to Coronavirus (COVID-19) Infographic
- March 19, 2021: FDA Authorizes First Machine Learning-Based Screening Device to Identify Certain Biomarkers That May Indicate COVID-19 Infection
- March 18, 2021: FDA authorizes revisions to fact sheets to address SARS-CoV-2 variants for monoclonal antibody products under emergency use authorization - FDA authorized revised fact sheets for health care providers to include additional information on susceptibility of SARS-CoV-2 variants to each of the monoclonal antibody (mAb) therapies that are available through an EUA for the treatment of COVID-19. FDA is providing this information to equip health care providers with the most current data so they can make informed decisions and provide appropriate care to patients with COVID-19. Health care providers should review the fact sheets for details regarding specific variants and potential resistance that may make the authorized mAb therapies less effective.
- March 18, 2021: FDA’s Ongoing Use of Inspectional Tools for Ensuring Access to Safe, Quality Food and Medical Products During the COVID-19 Pandemic
- March 17, 2021: MCMi email - Know your COVID-19 treatment options | New adverse event reporting dashboard
Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - During the virtual town hall, the FDA will share information and answer your questions about the development and validation of tests for SARS-CoV-2. Registration is not required. If you are unable to attend the live virtual town hall, the recording and transcript will be available for viewing the Tuesday after the live event. FDA will host additional webinars in this series on Wednesdays in April 2021.
May 26-27, 2021: Registration open! 2021 FDA Science Forum: Science as the Foundation for Protecting and Promoting Public Health (virtual) - FDA scientific experts and nationally renowned scientists will discuss eight topic areas including one on medical countermeasures, infectious disease, and pathogen reduction technologies. This year’s keynote speaker is NIAID Director Anthony Fauci, MD. Register now
June 9, 2021: Public workshop (virtual): Model Informed Drug Development Approaches for Immunogenicity Assessments - to discuss best practices and future directions of quantitative methods for predicting immunogenicity of biologic products - 8:00 a.m. - 5:00 p.m. ET - Register
June 14-18, 2021: Virtual Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories - Registration is open. Apply to attend by May 7, 2021.
Previous events: MCMi Events Archive
Learn More About COVID-19 Vaccines (Consumer Update)
#VaccineReady Social Media Toolkit with resources in English and Spanish, from FDA's Office of Minority Health and Health Equity
A Closer Look at COVID-19 Diagnostic Testing (for health care providers, test purchasers, and public health staff)
March 6, 2020: HHS Solicits Proposals for Development of Medical Products for Novel Coronavirus - As part of the government-wide effort to mitigate the spread of COVID-19 in U.S. communities, the U.S. Department of Health and Human Services (HHS) has updated a broad agency announcement (BAA) to focus specifically on products to diagnose, prevent or treat coronavirus infections. The Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), issued the BAA, BAA-18-100-SOL-00003-Amendment 13, to solicit proposals for advanced development and licensure of COVID-19 diagnostics, vaccines, or medicines such as therapeutics or antivirals.
February 5, 2020: HHS Seeks Abstract Submissions for 2019-nCoV Diagnostics Development - Under this EZ BAA, the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response, will review concise abstract submissions for development funding of 2019-nCoV molecular diagnostics. The diagnostics must utilize platforms already cleared by FDA, with a viable plan to meet requirements for the FDA to consider Emergency Use Authorization (EUA) within 12 weeks of an award.
January 30, 2020: BARDA is supporting U.S. government market research to identify medical countermeasures with the potential to help address the #2019nCoV outbreak. If your company is developing diagnostics, therapeutics, vaccines, or other products, submit your ideas to BARDA's online portal.
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