FDA Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency

On 30 August 2021 the FDA published updated guidance for industry, investigators, and Institutional Review Boards.

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 for the duration of the COVID-19 public health emergency. The appendix to this guidance further explains those general considerations by providing answers to questions that the Agency has received about conducting clinical trials during the COVID-19 public health emergency.

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