FDA issued draft guidance, Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics, regarding clinical trial design considerations to support accelerated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.
Cedars-Sinai performed the first robot-assisted microsurgical head-and-neck cancer reconstructive surgery in the United States after the robot device received FDA approval for the procedure.
