Coronavirus (COVID-19) Update: Daily Roundup September 1, 2020

FDA News Release

• For Immediate Release: September 01, 2020

The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic:

• The FDA has, jointly with the Federal Trade Commission (FTC), issued a warning letter to Lattice Biologics, Ltd., for marketing an unapproved amniotic fluid product, sometimes referred to as AmnioBoost, to mitigate, prevent, treat, diagnose or cure Severe Acute Respiratory Syndrome (SARS) or Acute Respiratory Distress Syndrome (ARDS) related to COVID-19.
• Testing updates:
  • To date, the FDA has currently authorized 235 tests under EUAs; these include 190 molecular tests, 41 antibody tests, and 4 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.