In light of the growing coronavirus (COVID-19) public health challenge, the FDA issued guidance on March 18 on general considerations for conducting clinical trials of medical products during the COVID-19 pandemic.
The guidance aims to “assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity.”
Partners Kathleen Sanzo and Jacqueline Berman provide key takeaways from the guidance in this LawFlash.