Beware of Fraudulent Coronavirus Tests, Vaccines and Treatments

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.