US FDA Advisory Committee Reboot (Part I): Open Public Meeting A Place To Start?
CDER Director Patrizia Cavazzoni raised eyebrows when she stated an intent to remove the ‘emotional overtone’ of committee meetings. The open public hearing may be a place to start.
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Survey of advisory committee members finds many believe an overwhelmingly negative vote should prevent a product approval. Survey was prompted by FDA accelerated approval of Alzheimer’s disease treatment Aduhelm despite overwhelming committee rejection.
A survey of advisory committee members finds many believe that an overwhelmingly negative vote should prevent a product approval.
Rethinking the voting and discussion questions to advisory committees may be one way to ensure FDA gets the advice it needs.