FDA News Release
Coronavirus (COVID-19) Update: November 12, 2020
- 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:
- Today, the FDA issued a new Consumer Update urging consumers to avoid fraudulent flu products and offering tips on how to spot them. These unproven products, sold online and in stores, haven’t been evaluated by the FDA for safety and effectiveness. Know that there are no legally marketed over-the-counter (non-prescription) drugs to prevent, mitigate, treat, or cure the flu. But there are legal over-the-counter (OTC) drugs to reduce fever and to relieve muscle aches, congestion, and other symptoms typically associated with the flu.The agency has been and will continue to take action against bad actors, as evidenced by warning letters we’ve sent to companies offering for sale medical products with fraudulent claims to prevent, mitigate, treat, or cure COVID-19.
- On November 10, the FDA updated the dashboard on the Coronavirus Treatment Acceleration Program (CTAP) webpage. As of October 31, more than 560 drug development programs were in planning stages, over 370 trials had been reviewed by FDA, 5 COVID-19 treatments were currently authorized for emergency use, and 1 treatment was approved by FDA for use in COVID-19.
- Testing updates:
- As of today, 288 tests are authorized by the FDA under EUAs; these include 223 molecular tests, 58 antibody tests, and 7 antigen tests.
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.
- Jane Hubbard