Comments on Draft Guidance, “Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial Is Underway”

The commenters support the FDA’s efforts to prevent delays in confirmatory trials for drugs granted accelerated approval and recommend that the agency require expedited timelines for drugs with serious safety signals, strengthen transparency around trial progress, and apply lessons from research showing that boxed warnings and early trial initiation are key factors in timely conversion to full approval.