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FDA Roundup: September 6, 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:  

  • Today, the FDA published the 2022: Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science (FARS) report, which outlines topics the agency has identified as needing continued targeted investment in regulatory science research to facilitate the development of innovative products, provide data and methods to inform regulatory decision-making and improve guidance to sponsors. This research facilitates evaluation or development of FDA-regulated products and supports regulatory decision-making and policy development. It also enables the FDA to understand and assess risk, prepare for and respond to public health emergencies, and help ensure the safety or reduce the harm of products used or consumed by patients and consumers. The 2022 report expands on cross-cutting topics and includes research, achievement and progress updates for focus areas included in the inaugural 2021 report.
  • 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 301 molecular tests and sample collection devices, 85 antibody and other immune response tests, 51 antigen tests, and 1 diagnostic breath test. There are 78 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, 19 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 for molecular OTC at-home tests.
    • The FDA has authorized 31 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1108 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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