- 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:
- On May 29, the FDA issued a new FDA Voices, Bringing a Cancer Doctor’s Perspective to FDA’s Response to the COVID-19 Pandemic. It explains how the agency plays a pivotal role helping to both move new medical products to patients as soon as possible and evaluate the potential benefits and risks of these new products.
- The FDA issued a Consumer Update, Understanding the Regulatory Terminology of Potential Preventions and Treatments for COVID-19. Scientists are working hard to develop a number of potential drugs for the prevention or treatment of coronavirus, but none are currently approved by the FDA for these purposes. The language used to describe potential therapies can be confusing, and there’s public interest around the FDA’s work to ensure access to potentially life-saving treatments. This Consumer Update explains some of the regulatory terminology.
- Testing updates:
- During the COVID-19 pandemic, the FDA has worked with more than 400 test developers who have already submitted, or said they will be submitting, EUA requests to the FDA for tests that detect the virus or antibodies to the virus.
- To date, the FDA has authorized 117 tests under EUAs, which include 101 molecular tests, 15 antibody tests, and 1 antigen 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.
- Lee Herring