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FDA Roundup: June 17, 2022

For Immediate Release:

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

  • On Thursday, the FDA’s National Center for Toxicological Research (NCTR) announced the publication of three International Test Method Standards in Nanotechnology by the American Society for Testing and Materials (ASTM) International. NCTR scientists conducted research with support from the National Institute of Environmental Health Sciences (NIEHS) toward the collaborative consensus-standards development for liposomes. These standards will increase predictability, streamline pre-market review, and facilitate new product entry to market.
  • The FDA has sent to Congress its Report on Drug Shortages for Calendar Year 2021, the ninth annual report to summarize major actions taken by the agency to prevent or mitigate drug shortages in the United States. While the number of new drug shortages has declined over the years, 2021 was a challenging year for shortages as manufacturers in the U.S. and abroad continue to experience quality issues and capacity constraints. Even still, the agency made important progress in helping to mitigate drug shortages. During CY 2021, there were 41 new shortages, and the FDA helped prevent 317 potential shortages.
  • COVID-19 testing updates:
    • As of today, 438 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 303 molecular tests and sample collection devices, 85 antibody and other immune response tests, 49 antigen tests, and 1 diagnostic breath test. There are 80 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for a molecular prescription at-home test, 2 EUAs for antigen prescription at-home tests, 17 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 for molecular OTC at-home tests.
    • The FDA has authorized 27 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1005 revisions to EUA authorizations.
       

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


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