FDA Reorganization Advocates Seek Senate Boost For Disease-Oriented Structure

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.

A proposal to reorganize FDA's medical product offices from a modality-based structure to one oriented by therapeutic area could gain more traction with the Senate's forthcoming draft of its medical innovation legislation.

A Friends of Cancer Research (FOCR) proposal to realign FDA according to disease area is drawing mixed reviews from current and former agency officials. Some say the agency's structure needs...

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