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FDA Press Releases·

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...