FDA Panel to Review Postmarket Requirements for Accelerated Approval Drugs

The FDA’s Oncologic Drugs Advisory Committee will meet Tuesday to discuss ways to improve the planning and conduct of postmarketing studies designed to confirm the clinical benefit of new drugs and biologics endorsed under accelerated approval. The overall aim of the meeting is to optimize the accelerated approval process by reducing the time required to confirm or disprove clinical benefit while maintaining early access to promising new cancer products. Specifically, the committee wants to know when a randomized trial should be required for accelerated approval and when single-arm studies are appropriate to confirm clinical benefit.
Drug Industry Daily