Beyond Aduhelm: OIG Review Will Put FDA’s Entire Accelerated Approval Program Under Microscope

 
• By Sarah Karlin-Smith

HHS Inspector General’s timeline means Congress won’t have findings to use during upcoming user fee renewal debate; ‘review’ is not an ‘investigation’ which could come with potentially more damning legal consequences for the agency.

FDA under OIG microscope (design by Nielsen Hobbs)
HHS OIG announced on 4 August a broad review of FDA's accelerated approval program • Source: Nielsen Hobbs

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