Skip to main content
FDA issues final guidance for trials amid coronavirus

The FDA has finalized new guidance offering recommendations on how drug firms can assure the safety of clinical trial participants, remain in compliance with good clinical practices and reduce trial integrity risks during the COVID-19 outbreak. The agency "recommends consultation with the appropriate review division regarding protocol modifications for the collection of efficacy endpoints, such as use of virtual assessments, delays in assessments, and alternative collection of research-specific specimens, if feasible."

Full Story: