For immediate release:

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

  • Today, the FDA’s Office of Global Policy and Strategy released “How a European Data Law Impacts the FDA,” which examines how the EU’s General Data Protection Regulation may have an impact on the public health activities of the FDA. So far, the FDA’s Biological Research Oversight 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 efforts to protect consumers, the agency issued a warning letter to FluxxLab LLC for selling unapproved and mislabeled dye products as drugs for use in the treatment or prevention of COVID-19. Consumers concerned about COVID-19 should consult their healthcare provider.
  • Dr. Janet Woodcock will deliver the keynote address at the FDA’s Small Business and Industry Assistance Regulatory Best Practices for Global Access to Medicines, including TB drugs. The agency hopes this event will help National Medicines Regulatory Authorities (NMRAs) in low- and middle-income (LMIC) countries better understand the FDA’s role in international regulatory harmonization; how the FDA interacts with the World Health Organization and NMRAs to support the drug approval process in LMICs and more.
  • COVID-19 testing updates:
    • To date, 439 tests and specimen collection devices are authorized by the FDA under Emergency Use Authorizations (EUAs). These include 302 molecular tests and sample collection devices, 85 antibody tests and other immune response tests, 51 antigen tests and 1 diagnostic breath test. There are 78 molecular clearances and 1 antibody clearance that can be used with home samples. There is 1 EUA for molecular prescription home testing, 2 EUA for antigen prescription home testing, 19 EUA for over-the-counter (OTC) antigen home testing and 3 for home testing Molecular OTCs.
    • The FDA has authorized 31 antigen tests and 8 molecular tests for serial screening programs. The FDA also authorized 1,072 revisions to EUA clearances.

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The FDA, an agency of the United States Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of the food supply, cosmetics, dietary supplements, electronic radiation emitting products and the regulation of tobacco products.