- For Immediate Release:
Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
- Today, the FDA authorized the marketing of four new tobacco products through the Premarket Tobacco Product Application (PMTA) pathway. The FDA issued marketing granted orders to NJOY LLC for its Ace closed e-cigarette device and three accompanying tobacco-flavored e-liquid pods, specifically, NJOY Ace Device, NJOY Ace Pod Classic Tobacco 2.4%, NJOY Ace Pod Classic Tobacco 5%, and NJOY Ace Pod Rich Tobacco 5%. The FDA also issued marketing denial orders to NJOY for multiple other Ace e-cigarette products. Applications for two menthol-flavored Ace e-liquid pods remain under FDA review.
- The FDA announced the May and June dates for the Virtual Town Hall Series for Test Developers on Coronavirus (COVID-19). The new time for the events will be from 12:05 p.m. – 1 p.m. ET
- COVID-19 testing updates:
- As of today, 431 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 296 molecular tests and sample collection devices, 84 antibody and other immune response tests, 50 antigen tests, and 1 diagnostic breath test. There are 77 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 28 antigen tests and 9 molecular tests for serial screening programs. The FDA has also authorized 945 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.