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Coronavirus Disease 2019 (COVID-19) updates
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Actions by FDA in our ongoing response to the COVID-19 pandemic since our last MCMi email update include:
- October 20, 2020: Daily roundup including new content on the "FDA Insight” podcast, in "FDA Voices," and a new Consumer Update
- October 20, 2020: The FDA’s Vaccines and Related Biological Products Advisory Committee and its Role in Advising the Agency on COVID-19 Vaccines, by Peter Marks, M.D., Ph.D., Director, FDA Center for Biologics Evaluation and Research (CBER)
- October 20, 2020: Consumer Update: Advisory Committees Give FDA Critical Expert Advice and the Public a Voice
- October 20, 2020: FDA Insight podcast: Advisory Committee on COVID-19 Vaccines
- October 15, 2020: FDA Reissues Emergency Use Authorization for Certain Non-NIOSH-Approved Filtering Face-Piece Respirators (FFRs) Manufactured in China
Bookmark www.fda.gov/coronavirus for the latest.
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 FDA approves first treatment for Ebola virus
On October 14, 2020, FDA approved Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn), a mixture of three monoclonal antibodies, as the first FDA-approved treatment for Zaire ebolavirus (Ebola virus) infection in adult and pediatric patients.
"This action demonstrates the FDA’s ongoing commitment to responding to public health threats—both domestically and abroad—on the basis of science and data,” said FDA Commissioner Stephen M. Hahn, M.D. “This approval was made possible because of our steadfast dedication to facilitate the development of safe and effective treatments for infectious diseases as part of our vital public health mission.”
Related links:
Advisory committees give FDA critical expert advice and the public a voice
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At FDA, we rely on our many advisory committees to help us make sound decisions based on the best science available.
FDA’s complex and multifaceted mission includes evaluating new medicines, including vaccines, to determine if they are safe and effective for their intended use. FDA advisory committees give our own agency experts outside, independent, and professional advice.
This Thursday, the FDA Vaccines and Related Biological Products Advisory Committee will discuss COVID-19 vaccine development generally. This process is transparent and independent, and open to the public. Read more
(October 20, 2020)
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Emergency Use Authorization (EUA) updates
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FDA reissues EUA for certain non-NIOSH-approved filtering facepiece respirators (FFRs) manufactured in China
FDA reissued the EUA (PDF) for certain FFRs that are manufactured in China and are not approved by the Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH). The FDA re-issued the EUA to authorize emergency use for only those respirators listed in the EUA’s Appendix A as of the date of this re-issuance. Effective immediately, this EUA no longer includes the three eligibility criteria that were included in the previous June 6, 2020 authorization letter, meaning the FDA will no longer be reviewing requests and adding new respirator models to Appendix A based on those criteria. (October 15, 2020)
Diagnostic test EUAs
As of today, 282 tests are authorized by FDA under EUAs; these include 220 molecular tests, 56 antibody tests, and 6 antigen tests Also see: Coronavirus Testing Basics
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Events
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Today! October 21, 2020: Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - FDA will host a virtual Town Hall for SARS-CoV-2 test developers, 12:15 p.m. - 1:15 p.m. ET. The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2. FDA will host additional town halls in this series on Wednesdays in October. To ensure you are connected, please dial-in at 12:00 p.m. ET
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October 22, 2020: Vaccines and Related Biological Products Advisory Committee (webcast) - The committee will meet to discuss, in general, the development, authorization, and/or licensure of vaccines to prevent COVID-19. No specific application will be discussed at this meeting. Event materials;10:00 a.m. - 5:00 p.m. ET live broadcast
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October 22-23, 2020: FDA Public Workshop: Pediatric Dose Selection (virtual) - FDA, in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), will host a two-day virtual public workshop to discuss the present state of dose selection and how it pertains to pediatric drug development. This workshop is intended for clinicians, drug developers, and regulators. Pre-registration is required.
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October 27, 2020: Save the date for the next event in FDA's webinar series to share information and answer your questions on respirators and other personal protective equipment (PPE). Printable slides and transcripts from previous events in this series are available.
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November 16, 2020: FDA Public Meeting on Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial Animal Drugs (virtual) - Register by November 12, 2020.
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Information for industry
Medical devices
FDA is committed to providing timely recommendations, regulatory information, guidance, and technical assistance necessary to support rapid COVID-19 response efforts. FDA has issued more than 60 COVID-19-related guidances to date.
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In case you missed it
COVID-19 Vaccines
FDA has rigorous scientific and regulatory processes in place to facilitate development and ensure the safety, effectiveness and quality of COVID-19 vaccines. Get the latest: www.fda.gov/covid19vaccines
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It’s a good time to get your flu vaccine
Haven’t had your flu shot yet? It’s not too late. And there are still good reasons to get one.
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COVID-19 resources for health professionals
Find information about medical products FDA has authorized for emergency use, frequently asked questions about personal protective equipment (PPE), a Patient Outreach Toolkit, and more.
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