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MCMi News and Events

Medical countermeasure and public health emergency news and events from FDA and partners

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Featured news and events

  • July 21, 2021: FDA’s Budget: Medical Device Supply Chain and Shortages Prevention Program - The investments outlined in the FDA’s FY 2022 budget include $21.6 million for a new Resilient Supply Chain and Shortages Prevention Program (RSCSPP) in the Center for Devices and Radiological Health (CDRH). This funding will provide, for the first time, resources to establish a permanent program for U.S. supply chain resilience for medical devices. The funding will help to stand up this program, which will build on the work done to implement the CARES Act during the COVID-19 public health emergency, and will focus on strengthening the domestic supply chain through investments in preventive measures, identifying potential medical product supply short-falls, continuing surveillance, and rapid intervention. 

  • July 21, 2021: MCMi email - COVID-19 updates | Register now to learn about clinical trials involving high-consequence pathogens

  • July 20, 2021: The Path Forward: A Federal Perspective on the COVID-19 Response - Testimony of Acting Commissioner Janet Woodcock, MD, before the Senate Committee on Health, Education, Labor, and Pensions

  • July 19, 2021: 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.  

  • July 19, 2021: 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."  

  • July 16, 2021: As Pfizer announced (PDF, 209 KB), 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 15, 2021: 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: 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, 223 KB) 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 14, 2021: MCMI email - Hear from FDA leaders on Emergency Use Authorization | COVID-19 vaccine updates

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