FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic

On 18 March 2020 the FDA issued this final guidance for industry, investigators and IRBs and on 27 March updated it.

FDA is issuing this guidance 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. The appendix to this guidance further explains those general considerations by providing answers to questions about conducting clinical trials that the Agency has received during the COVID-19 pandemic.

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