Beyond Aduhelm: OIG Review Will Put FDA’s Entire Accelerated Approval Program Under Microscope
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.
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One of the US FDA’s most prominent review managers is retiring after nearly 25 years with the agency. Ellis Unger’s departure underscores a sense of transition in the leadership and mindset of the drug center.
In report language, the committee funds more CBER cell and gene therapy staff for rare diseases and suggests AI be considered to speed up complex generic assessments.
CDER director says agency has many tools to expedite development and does not endorse adding a pathway similar to EU’s conditional approval. Neurodegenerative diseases hearing in Energy & Commerce Committee focuses more on ALS than Aduhelm.