For immediate release: May 25, 2021
The U.S. Food and Drug Administration today announced the following actions in its ongoing effort to respond to the COVID-19 pandemic:
- Today, the FDA has updated its guidelines, Emergency Use Authorization for Vaccines to Prevent COVID-19, to include a new section that clarifies how the agency intends to prioritize the review of applications for US for other public health emergencies COVID-19. As stated in the guide, for the remainder of the current pandemic, the FDA may refuse to review and process other U.S. applications other than the vaccines whose developers have already collaborated. with the agency, as described in the agency guide, “Emergency Use Authorization Vaccines”. to avoid COVID-19 “.
- Today the FDA released a report describing some of the approaches used by the South Korean government to address COVID-19, particularly with respect to the development, authorization, and use of diagnostic tests. Numerous sources around the world stated that South Korea’s response strategy had “successfully flattened the curve” of COVID-19. Because the South Korean experience may be informative for future consideration, the FDA reviewed information, including press reports and information that the South Korean government made public, about its response strategy. COVID-19.
- Test updates:
- To date, 378 tests and sample collection devices are authorized by the FDA under emergency use authorizations (US). These include 273 molecular tests and sample collection devices, 80 antibody and other immune response tests, and 25 antigen tests. There are 51 molecular clearances and one antibody clearance that can be used with samples collected at home. There is one home molecular prescription test, two home antigen prescription tests, four home antigen (OTC) prescription tests, and two home molecular reception tests.
- The FDA has authorized nine antigen tests and four molecular tests for serial screening programs. The FDA has also authorized 510 revisions to U.S. authorizations.
The FDA, an agency of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and security of human and veterinary drugs, vaccines, and other biological products for human use and medical devices. The agency is also responsible for the security of our nation’s food supply, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products.
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