US FDA Advisory Committees Could Get Revamp With A Focus On Science Over Emotion
CDER Director Cavazzoni also wants to loosen conflict of interest rules and improve technology for remote meetings. Given FDA’s approval of Aduhelm, her comments, made in a prerecorded interview for the BIO Digital annual meeting, may raise some eyebrows. Industry is also working on recommendations for the agency on the topic.
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Despite acknowledging that fully in-person meetings overall are better, survey respondents said they still want the flexibility that virtual attendance offers.
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.
Agency officials are considering developing policies for when an advisory committee meeting is appropriate, in part because of the workload associated with them. Could fewer meetings result?