September 7, 2021 - Coronavirus (COVID-19) Update: September 7, 2021

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

• As part of the FDA’s effort to protect consumers, the agency issued a warning letter to Kaleido Biosciences, Inc. for not complying with federal laws and regulations, including laws and regulations to protect individuals participating in clinical trials, during the clinical investigation of an investigational drug to mitigate and treat COVID-19. Sponsors seeking to develop new drugs to treat or prevent any disease, including COVID-19, must comply with the FDA’s laws and regulations governing clinical trials of investigational drugs.
• Testing updates: 
  • As of today, 409 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 287 molecular tests and sample collection devices, 88 antibody and other immune response tests, and 34 antigen tests. There are 62 molecular authorizations that can be used with home-collected samples. There is one molecular prescription at-home test, three antigen prescription at-home tests, seven over-the-counter (OTC) at-home antigen tests, and two OTC molecular tests. 
  • The FDA has authorized 14 antigen tests and eight molecular tests for serial screening programs. The FDA has also authorized 622 revisions to EUA authorizations.
     

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