FDA Summary: June 17, 2022
- For immediate release:
Today, the U.S. Food and Drug Administration provides an at-a-glance summary of news from the agency:
- On Thursday, the FDA’s National Center for Toxicology Research (NCTR) announced the publication of three international standards for nanotechnology test methods by the American Society for Testing and Materials (ASTM) International. NCTR scientists conducted research with the support of the National Institute of Environmental Health Sciences (NIEHS) toward the collaborative development of consensus standards for liposomes. These standards will increase predictability, streamline pre-market review and make it easier for new products to enter the market.
- The FDA has sent Congress its Drug Shortages Report for Calendar Year 2021, the ninth annual report summarizing key actions the agency is taking to prevent or alleviate drug shortages in the United States. While the number of new drug shortages has declined over the years, 2021 has been a tough year for shortages as manufacturers in the U.S. and abroad continue to experience quality issues and capacity constraints. . Even still, the agency has made significant strides to help alleviate drug shortages. During CY 2021, there were 41 new shortages and the FDA helped prevent 317 potential shortages.
- COVID-19 testing updates:
- To date, 438 tests and specimen collection devices are authorized by the FDA under Emergency Use Authorizations (EUAs). These include 303 molecular tests and sample collection devices, 85 antibody tests and other immune response tests, 49 antigen tests and 1 diagnostic breath test. There are 80 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, 17 EUA for over-the-counter (OTC) antigen home testing and 3 for home testing Molecular OTCs.
- The FDA has authorized 27 antigen tests and 8 molecular tests for serial screening programs. The FDA also authorized 1005 EUA clearance revisions.
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.