- 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:
- The agency has updated its FDA COVID-19 Response At-A-Glance Summary, which provides a quick look at facts, figures, and highlights on the FDA’s response efforts.
- FDA has posted a CDER Conversation with Katie Gray, Pharm.D., acting director of CDER’s Office of Prescription Drug Promotion (OPDP). This Conversation describes OPDP’s COVID-19 response, which has focused on compliance actions regarding prescription drug promotional materials making false or misleading claims about COVID-19 prevention or treatment. The Conversation also discusses OPDP’s 2020 achievements and 2021 goals, and the way the office continues to streamline operations to fulfill its public health mission.
- Testing updates:
- As of today, 320 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 238 molecular tests and sample collection devices, 69 antibody tests, and 13 antigen tests. There are 33 molecular authorizations that can be used with home-collected samples. There is one molecular prescription at-home test, one antigen prescription at-home test, and one over-the-counter (OTC) at-home 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.