FDA Coronavirus (COVID-19) Update: July 24th, 2020

Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:

Today, the FDA updated the Testing Supply Substitution Strategies slide show.

This presentation includes validated supply alternatives that labs can use to continue performing testing when there is a supply issue with some components of a molecular test.

Download the 1.5MB PowerPoint slide show file and click Slide Show > From Beginning.

This week, FDA and the Federal Trade Commission issued a joint warning letter to 21st Century LaserMed Pain & Regenerative Medicine Institute (d/b/a Create Wellness Clinics) for offering unapproved, unlicensed, uncleared and unauthorized products for the mitigation, prevention, treatment, diagnosis or cure of COVID-19 Coronavirus.

There are currently no FDA-approved products to prevent or treat COVID-19 Coronavirus. Consumers concerned about COVID-19 Coronavirus should consult with their health care provider.

Testing updates:

To date, the FDA has currently authorized 187 tests under EUAs; these include 154 molecular tests, 31 antibody tests, and 2 antigen tests.

About the U.S. Food and Drug Administration

The U.S. Food and Drug Administration (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.