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  5. FDA Roundup: August 23, 2022
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FDA News Release

FDA Roundup: August 23, 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’s Office of Global Policy and Strategy posted an article about the FDA’s fruitful partnership with the Inter-American Institute for Cooperation in Agriculture or IICA — an agency working to advance agricultural development and rural well-being across the Americas. IICA is helping to facilitate the implementation of the FDA’s Food Safety Modernization Act requirements in Latin America. 
  • On August 22, the FDA and the Duke-Margolis Center for Health Policy announced a virtual public workshop on October 11 titled, “Challenges and Opportunities for REMS Integration, Innovation, and Modernization.” The workshop will solicit feedback from key stakeholders on a Risk Evaluation and Mitigation Strategies (REMS) integration prototype. Speakers from FDA and MITRE will lead the workshop with patients, prescribers, pharmacists, health system representatives, informaticists, and other key stakeholders participating in a series of moderated panel discussions focusing on how the prototype can address challenges associated with integrating REMS requirements into clinical workflows to facilitate safe medication use.
  • COVID-19 testing updates:  
    • As of today, 439 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 302 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 1091 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.


FDA Office of Media Affairs

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