Accelerated Approvals Convert Much Faster If Confirmatory Trial Already Underway, FDA Cancer Data Shows

15 Jul 2022

• By Kate Rawson

Oncology Center of Excellence’s ‘Project Confirm’ finds that if a confirmatory trial is ongoing at the time of accelerated approval, conversion to regular approval takes an average of three years versus 4.9 years if the trial starts after AA.

Clinical trial — Confirmatory trial status at approval is one of the most important factors in converting an accelerated approval to a full approval, FDA said. • Source: Shutterstock

Accelerated Approvals Convert Much Faster If Confirmatory Trial Already Underway, FDA Cancer Data Shows

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