Look Before Leaping To Reorganize FDA – Former Commissioner McClellan
This article was originally published in The Tan Sheet
The former commissioner says FDA has to think about getting biggest bang for the buck when considering a reorganization to disease-focused teams, particularly aimed at combination product reviews, which have been problematic because the drug and device review schedules often do not mesh.
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The agency is still working to get an oncology center of excellence off the ground and has other large pending reorganizations to tackle before it may get to creating additional centers intended to break down device, drug and biologic silos.
Agency is still working to get oncology center of excellence off the ground and has other large pending reorganizations that could take precedence.
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.