Oncology Drug Reviews To Be Restructured As Office Shifts Away From Divisions Organized Around Molecule Size
FDA's Office of Oncology Drug Products is undergoing a reorganization aimed at making its structure more similar to the rest of the review offices in the Center for Drug Evaluation and Research
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Friends of Cancer Research proposes realignment of medical product functions by disease area without regard to modality; former commissioners give some support but new drugs Director Jenkins warns about unintended consequences that could negatively impact innovation and approvals.
Friends of Cancer Research proposes realignment of FDA to be organized more around disease areas and less around the distinctions between drugs, devices and biologics. The idea has generated some support from former commissioners and current officials, while others warn of unintended consequences.
Many NDAs, BLAs and INDs for cancer drugs are being reassigned to new review divisions as part of a reorganization of FDA’s Office of Oncology Drug Products.