MCMi News and Events
Medical countermeasure and public health emergency news and events from FDA and partners
Featured news and events
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Coronavirus Disease 2019 (COVID-19) updates from FDA, including the latest news, FAQs, and more
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Register now for the 2021 FDA Science Forum: Science as the Foundation for Protecting and Promoting Public Health (virtual), May 26-27, 2021.
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Registration closes May 14, 2021 for the June 14-18, 2021 virtual training course: Achieving Data Quality and Integrity in Maximum Containment Laboratories.
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May 12, 2021: MCMi email - FDA authorizes Pfizer-BioNTech COVID-19 Vaccine for emergency use in adolescents
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May 7, 2021: Important update about bamlanivimab/etesevimab with regard to the P.1 variant in the state of Illinois (from ASPR and FDA)
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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).
- May 12, 2021: MCMi email - FDA authorizes Pfizer-BioNTech COVID-19 Vaccine for emergency use in adolescents
- May 11, 2021: An Update from Federal Officials on Efforts to Combat COVID-19 - Testimony from Dr. Peter Marks, Director of the FDA Center for Biologics Evaluation and Research, before the U.S. Senate Committee on Health, Education, Labor and Pensions
- May 10, 2021: FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents in Another Important Action in Fight Against Pandemic - FDA expanded the EUA for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to include adolescents 12 through 15 years of age. The FDA amended the EUA originally issued on Dec. 11, 2020 for administration in individuals 16 years of age and older.
- May 10, 2021: FDA In Brief: FDA to Hold Meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to Discuss Pediatric Use of COVID-19 Vaccines - FDA will hold a VRBPAC meeting on June 10, 2021 to provide a status update on our approach to Emergency Use Authorization (EUA) for COVID-19 vaccines intended for use in individuals 12 through 17 years of age. The committee will also discuss the data needed to support an EUA and a Biologics License Application (BLA) for a COVID-19 vaccine intended for use in children less than 12 years of age. The committee will not discuss any specific products.
- May 10, 2021: Hurricane Season: Be Prepared - National Hurricane Preparedness Week is May 9-15, 2021. It's important to safeguard your food, water, medicine and pets before, during and after any severe weather event.
- May 7, 2021: Important update about bamlanivimab/etesevimab with regard to the P.1 variant in the state of Illinois (from ASPR and FDA)
- May 5, 2021: FDA Outlines Inspection and Assessment Activities During Pandemic, Roadmap for Future State of Operations
- May 5, 2021: MCMi email - Safely using hand sanitizer + more COVID-19 response updates from FDA
- April 30, 2021: FDA revoked (PDF) the EUA of the Battelle CCDS Critical Care Decontamination System which was authorized for use in decontaminating compatible N95 respirators for multiple-user reuse by healthcare personnel. FDA revoked the EUA in response to Battelle’s request for voluntary withdrawal of the authorization. In response to changing customer needs, as of March 31, 2021, Battelle has ceased all Battelle CCDS decontamination site operations and marketing activities. As a reminder, decontaminated respirators and respirators that have undergone bioburden reduction should be used only when there are insufficient supplies of new filtering facepiece respirators (FFRs) or any new respirators. On April 9, 2021, FDA issued a letter to healthcare providers recommending transitioning from use of decontaminated disposable respirators. Additional information about revoked EUAs is available on the FDA website (see: Emergency Use Authorization--Archived Information).
- April 28, 2021: FDA updated the EUA Authorized Serology Test Performance page. The FDA provided information on the expected predictive value of authorized serology tests that have submitted performance data with SARS-CoV-2 antibody prevalence assumptions ranging from 5% to 50%. These estimates may help health care providers interpret these antibody test results for their patients. Additionally, the updated web page clarifies the use of serology tests when assessing a patient’s adaptive immune response.
- April 28, 2021: MCMi email - COVID-19 vaccine updates from FDA
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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 May and June 2021.
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May 26-27, 2021: 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
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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
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June 10, 2021: Vaccines and Related Biological Products Advisory Committee to Discuss Pediatric Use of COVID-19 Vaccines - to provide a status update on our approach to Emergency Use Authorization (EUA) for COVID-19 vaccines intended for use in individuals 12 through 17 years of age. The committee will also discuss the data needed to support an EUA and a Biologics License Application (BLA) for a COVID-19 vaccine intended for use in children less than 12 years of age. The committee will not discuss any specific products.
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June 14-18, 2021: Virtual Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories - Registration is open. Apply to attend by May 14, 2021.
Previous events: MCMi Events Archive
General information
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COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders
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Coronavirus Disease 2019 (COVID-19) Resources for Health Professionals
Vaccines
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Learn More About COVID-19 Vaccines (Consumer Update)
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The Path for a COVID-19 Vaccine from Research to Emergency Use Authorization (PDF, 723 KB)
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#VaccineReady Social Media Toolkit with resources in English and Spanish, from FDA's Office of Minority Health and Health Equity
Therapeutics
Testing
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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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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.
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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.
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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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Product shortages and availability
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More FDA news and events
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