FDA issued draft guidance, Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics, regarding clinical trial design considerations to support accelerated approval applications. The accelerated approval pathway is commonly used for approval of oncology drugs in part due to the serious and life-threatening nature of cancer and because of available intermediate clinical endpoints likely to predict clinical benefit.
FDA Center for Drug Evaluation and Research is soliciting grant applications from independent organizations to support meetings that bring together a broad range of stakeholders to explore, research, and address issues related to medical products, policy, and surveillance methods and systems.
