- For Immediate Release:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- Today, the FDA updated its guidance, Emergency Use Authorization for Vaccines to Prevent COVID-19, to include a new section that clarifies how the agency intends to prioritize review of EUA requests for the remainder of the COVID-19 public health emergency. As noted in the guidance, for the remainder of the current pandemic, the FDA may decline to review and process further EUA requests other than those for vaccines whose developers have already engaged with the agency as described in the agency’s guidance, “Emergency Use Authorization Vaccines to Prevent COVID-19.”
- Today the FDA issued a report that describes some of the approaches used by the South Korean government to address COVID-19, particularly regarding development, authorization and use of diagnostic tests. Numerous sources around the world declared South Korea’s response strategy had successfully “flattened the curve” of COVID-19. As South Korea’s experience may be informative for future considerations, the FDA reviewed information, including reports in the press and information made publicly available by the South Korean government, about their COVID-19 response strategy.
- Testing updates:
- As of today, 378 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 273 molecular tests and sample collection devices, 80 antibody and other immune response tests, and 25 antigen tests. There are 51 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one molecular prescription at-home test, two antigen prescription at-home tests, four antigen over-the-counter (OTC) at-home tests and two molecular OTC at-home tests.
- The FDA has authorized nine antigen tests and four molecular tests for serial screening programs. The FDA has also authorized 510 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.