News: FDA updates its guidance on clinical trial amidst the pandemic
The U.S. Food and Drug Administration (FDA) has successfully updated its clinical trial amidst the COVID-19 crisis that addresses new questions concerning the post-marketing requirements, video conferencing, and imaging centers. The updated guidance now has a total set of 20 questions with newly amended three questions and answers.
The FDA also explains that it considers real-time video interactions to be “a live exchange of information between the personnel and trial participants,” and not as electronic records subject to 21 CFR part 11. FDA additionally added that the guidance also provides some considerations for sponsors looking to use video conferencing in lieu of participant site visits.