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FDA Roundup: August 9, 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 published “How a European Data Law is Impacting FDA,” which looks at how the European Union’s General Data Protection Regulation may be impacting the FDA’s public health activities. So far, the FDA’s bioresearch monitoring program, which oversees the conduct and reporting of FDA-regulated research, has been most affected by the law.  
  • On August 4, as part of the FDA’s effort to protect consumers, the agency issued a warning letter to FluxxLab LLC for selling unapproved and misbranded tincture products as drugs for use in treating or preventing COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.
  • Dr. Janet Woodcock will deliver the keynote address at the FDA CDER Small Business and Industry Assistance Regulatory Best Practices for Global Access to Medicines, Including Anti-TB Medicines. The agency intends for this event to help national medicines regulatory authorities (NMRAs) in low-and middle-income countries (LMICs) gain a better understanding of the FDA’s role in international regulatory harmonization; how the FDA interacts with the World Health Organization and NMRAs to support the process for approving drugs in LMICs and more.
  •  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 1072 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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