Coronavirus (COVID-19) Update: Daily Roundup September 21, 2020

FDA News Release

• For Immediate Release: September 21, 2020

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

• A new video entitled, Beware of Fraudulent Coronavirus Tests, Vaccines and Treatments, explains to consumers that there are currently no FDA-approved drugs or vaccines to treat or prevent COVID-19. Products that fraudulently claim to cure, treat, diagnose, or prevent COVID-19 haven’t been evaluated by the FDA for safety and effectiveness for such use, and they might be dangerous to you and your family.
• The FDA has added content to the question-and-answer appendix in its guidance titled “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.” The updated guidance includes a new question-and-answer regarding a clinical trial investigator’s responsibility to review all investigational new drug application safety reports, including reports that will not result in a change to the investigator brochure, informed consent, or protocol.
• Testing updates:
  • As of today, 249 tests are authorized by FDA under EUAs; these include 199 molecular tests, 46 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.