FDA Issues Updated Guidance on Clinical Trial Conduct During the COVID-19 Pandemic

FDA Issues Updated Guidance on Clinical Trial Conduct During the COVID-19 Pandemic

On March 18, 2020, FDA issued “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic” to provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity during the COVID-19 pandemic.  On March 27, 2020, FDA amended the guidance to include an appendix to further explain those general considerations by providing answers to questions about conducting clinical trials that the Agency has received during the COVID-19 pandemic.  For the updated guidance, please see:  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-pandemic. 

For additional questions regarding clinical trial conduct during the COVID-19 pandemic, please email Clinicaltrialconduct-COVID19@fda.hhs.gov.