FDA Releases Guidance on Clinical Trial Conduct During COVID-19 Pandemic

FDA Releases Guidance on Clinical Trial Conduct During COVID-19 Pandemic

March 19, 2020, Covington Alert

The U.S. Food and Drug Administration (FDA) released guidance on March 18, 2020 entitled “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic” (Guidance).1 The Guidance comes at a critical time, as clinical trial sponsors, investigators, and Institutional Review Boards (IRBs) grapple with the measures needed to ensure the safety of clinical trial participants while maintaining good clinical practice (GCP) and preserving clinical trial integrity during this unprecedented public health emergency. FDA is implementing the recommendations in the Guidance immediately, but comments may still be submitted to the Agency for consideration.