FDA Issues Draft Guidance Aimed at Improving Oncology Clinical Trials for Accelerated Approval
March 25, 2023
March 25, 2023
WASHINGTON, March 25 -- The U.S. Department of Health and Human Services' Food and Drug Administration issued the following news release on March 24, 2023:
The U.S. Food and Drug Administration issued draft guidance, Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics, regarding clinical trial design considerations to support accelerated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 . . .
The U.S. Food and Drug Administration issued draft guidance, Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics, regarding clinical trial design considerations to support accelerated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 . . .