FDA Roundup: May 31, 2022
Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
The FDA’s Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), and Center for Biologics Evaluation and Research (CBER) are pleased to invite you to their free, virtual Regulatory Education for Industry (REdI) Annual Conference 2022 which will be held June 6 through June 10. The event’s keynote speaker will be Dr. Robert M. Califf, Commissioner of Food and Drugs, and the plenary will reflect on COVID-19 with some of FDA’s noteworthy milestones and landmark accomplishments. It will also look ahead at FDA’s future activities in the fight against COVID-19. Learn directly from the FDA’s regulatory experts in medical product centers: drugs, devices, and biologics. This course is designed to provide participants with a strong, basic foundation in the FDA’s regulatory requirements. Registration and attendance are free. Visit the event pageExternal Link Disclaimer to register and view the agendaExternal Link Disclaimer. This event will offer a total of 32.5 contact hours of continuing education for physicians, pharmacists, and nurses.
COVID-19 testing updates:
As of today, 436 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 302 molecular tests and sample collection devices, 84 antibody and other immune response tests, 49 antigen tests, and 1 diagnostic breath test. There are 80 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for a molecular prescription at-home test, 2 EUAs for antigen prescription at-home tests, 17 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 for molecular OTC at-home tests.
The FDA has authorized 27 antigen tests and 7 molecular tests for serial screening programs. The FDA has also authorized 993 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.