- 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:
- In a March 22 Consumer Update, the FDA provided an update on simple steps to help slow the spread of coronavirus disease to protect ourselves, our families and our communities. Read more: Help Stop the Spread of Coronavirus and Protect Your Family.
- The FDA and the NIH CURE ID app has received the 2021 Golan Christie Taglia Patient Impact Philanthropy Award from Cures Within Reach. CURE ID is an internet-based repository that lets the clinical community share novel uses of existing drugs for difficult-to-treat infectious diseases. The FDA and the NIH have made critical updates to CURE ID to be a more effective tool during COVID-19.
- As part of the FDA’s effort to protect consumers, the agency issued a warning letter jointly with the Federal Trade Commission to PYRLess Group, LLC dba Dr. Fitt for selling unapproved products with fraudulent COVID-19 claims. The FDA requested that the company take immediate action to cease the sale of any unapproved and misbranded products for the treatment or prevention of COVID-19. Consumers concerned about COVID-19 should consult with their health care providers.
- Testing updates:
- As of today, 343 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 255 molecular tests and sample collection devices, 73 antibody and other immune response tests, and 15 antigen tests. There are 41 molecular authorizations that can be used with home-collected samples. There is one molecular prescription at-home test, two antigen prescription at-home tests, one over-the-counter (OTC) at-home antigen test, and one OTC molecular test.
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.
- Kim DiFonzo