| Coronavirus Disease 2019 (COVID-19) updates Actions by FDA in our ongoing response to the COVID-19 pandemic since our last MCMi email update include: - July 20, 2021: COVID-19 Update including FDA testimony before the U.S. Senate Committee on Health, Education, Labor and Pensions
- July 20, 2021: The Path Forward: A Federal Perspective on the COVID-19 Response - Hearing before the U.S. Senate Committee on Health, Education, Labor and Pensions; Acting Commissioner Janet Woodcock, M.D. testified for the FDA
- July 16, 2021: COVID-19 Update including FDA formally accepting the Biologics License Application (BLA) for the Pfizer-BioNTech mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older, and granting the application priority review
Bookmark www.fda.gov/coronavirus for the latest. | | | COVID-19 vaccine updates BLA accepted, granted priority review As Pfizer announced (PDF) on July 16, 2021, the FDA has formally accepted the company's Biologics License Application (BLA) requesting licensure (approval) of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 in individuals 16 years of age and older and has granted the application priority review. Currently, the vaccine is authorized for emergency use to prevent COVID-19 in individuals ages 12 and older. The Prescription Drug User Fee (PDUFA) Goal Date of January 2022 reflects the PDUFA deadline for Priority Review and does not mean approval will not happen before that time. Quite to the contrary, the review of this BLA has been ongoing, is among the highest priorities of the agency, and the agency intends to complete the review far in advance of the PDUFA Goal Date. (July 16, 2021) Concerned about vaccine side effects? COVID-19 is worse. "COVID-19 is a much worse disease than any of these rare risk factors ... COVID-19 is very real, and it's unfortunately very much still with us. The risks of these rare side effects are greatly outweighed by the potential benefits of getting vaccinated." - Dr. Peter Marks, Director, FDA Center for Biologics Evaluation and Research (CBER), at a July 15, 2021 stakeholder call on vaccines Text your zip code to GETVAX (438829) in English or VACUNA (822862) in Spanish to find out where COVID-19 vaccines are available near you. Learn more at vaccines.gov. Vaccine recipient EUA fact sheet updates in multiple languages Did you know? FDA posts COVID-19 vaccine EUA fact sheets for recipients in more than 25 languages. If you reference these fact sheets, or share them with patients, please bookmark these pages so you'll always have the latest information. An FDA Consumer Update, Learn More About COVID-19 Vaccines From the FDA, is now available in five additional languages: Spanish, Chinese, Korean, Tagalog, and Vietnamese. See the evidence for each COVID-19 vaccine and the reasoning behind the FDA's Emergency Use Authorizations. Global regulators envision paradigm shift toward inclusion of pregnant and breastfeeding women in clinical research for medicines and vaccines "Even before COVID-19 shined a spotlight on this important issue, an escalating drumbeat of interest emerged from the FDA and other regulators to address information gaps that leave pregnant and breastfeeding women, along with their health care providers, to make important clinical decisions on the basis of scant data. We believe it is time for change so that pregnant women and their doctors will not be tasked with weighing the benefits and risks of treatment in the absence of information." | | Emergency Use Authorization (EUA) updates Revocation of the Curative SARS-Cov-2 Assay EUA Curative, Inc. requested that the FDA revoke the EUA for its test, the Curative SARS-Cov-2 Assay, effective July 15, 2021 because it will no longer be using that test. Curative, Inc. is offering different EUA-authorized SARS-CoV-2 tests for the testing offered at its laboratories. Accordingly, on July 15, 2021, the FDA revoked (PDF) EUA200132 for the Curative SARS-Cov-2 Assay, pursuant to section 564(g)(2)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). As of July 15, 2021, the Curative SARS-Cov-2 Assay is no longer authorized for emergency use by the FDA. (July 15, 2021) New product codes for certain medical devices authorized for emergency use under EUAs FDA has created new product codes for certain medical devices authorized for emergency use under EUA. An applicable product code has been assigned to each authorized device category. The product codes are listed in the tables for each category of devices that have EUAs. The categories of devices are available on the Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices page. (July 15, 2021) In vitro diagnostic (test) EUAs As of July 20, 2021, 396 tests and sample collection devices are authorized by FDA under EUAs. These include 281 molecular tests and sample collection devices, 85 antibody and other immune response tests, and 30 antigen tests. There are 52 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 molecular prescription at-home test, 3 antigen prescription at-home tests, 5 antigen over-the-counter (OTC) at-home tests, and 2 molecular OTC at-home tests. FDA has authorized 11 antigen tests and 7 molecular tests for serial screening programs. The FDA has also revised 576 test EUAs. Also see: Coronavirus Testing Basics | | | Events - July 28, 2021: Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation, 12:15 p.m. - 1:15 p.m. ET, hosted by FDA's Center for Devices and Radiological Health (CDRH)
- August 2-4, 2021: Virtual Training Course: Achieving Data Quality and Integrity in Clinical Trials Involving High-Consequence Pathogens - Register by July 26, 2021.
- New! August 25, 2021: Manufacturing, Supply Chain, and Inspections during the COVID-19 Public Health Emergency webinar, 9:00 a.m. - 1:00 p.m. ET, hosted by FDA's Center for Drug Evaluation and Research (CDER)
- New! August 30 - September 1, 2021: Science and Regulation of Bacteriophage Therapy public workshop, hosted by FDA CBER and the National Institutes of Health, National Institute of Allergy and Infectious Diseases (NIH/NIAID)
| | Information for industry 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 75 COVID-19-related guidances to date. | | In case you missed it COVID-19's impact on medical product operations This week, FDA hosted the SBIA REdI Annual Conference. On Monday, FDA leaders discussed FDA's use of EUAs and other resources in making medical products available to support the public health response to the COVID-19 pandemic. Listen to Day 1 and additional sessions on the FDA YouTube channel. | FDA's COVID-19 response See the updated FDA COVID-19 Response At-A-Glance Summary (PDF) for a quick look at facts, figures and highlights of the agency's response efforts. (July 19, 2021) | List of hand sanitizers consumers should not use Some hand sanitizers have been recalled and there are more than 250 hand sanitizers the FDA recommends you stop using right away. Bookmark www.fda.gov/handsanitizerlist for the latest, and use our step-by-step search guide to find out if your product is on the list. | Did someone forward you this email? Subscribe. (Select Emergency Preparedness and Response, FDA Medical Countermeasures Initiative (MCMi) News)
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