- For Immediate Release:
The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic:
- The FDA has sent to Congress its Report on Drug Shortages for Calendar Year 2020, which includes a section on the agency’s drug shortage efforts in response to COVID-19. These actions include reminding manufacturers to notify the FDA of permanent discontinuances or interruptions in manufacturing and asking them to evaluate their supply chain. In addition, the FDA has leveraged various tools, such as expediting reviews, exercising enforcement discretion and publishing guidances, with the goal of increasing patient access to medications in shortage or preventing potential shortages. The FDA is also working to implement the drug shortage-related provisions of the Coronavirus Aid, Relief, and Economic Security Act.
- Testing updates:
- As of today, 389 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 278 molecular tests and sample collection devices, 83 antibody and other immune response tests and 28 antigen tests. There are 52 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one molecular prescription at-home test, three antigen prescription at-home tests, five antigen over-the-counter (OTC) at-home tests and two molecular OTC at-home tests.
- The FDA has authorized 11 antigen tests and three molecular tests for serial screening programs. The FDA has also authorized 553 revisions to EUA authorizations.
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.