Power To The (Adcomm) People: Members Believe Votes Should More Directly Affect US FDA Decisions
A survey of advisory committee members finds many believe that an overwhelmingly negative vote should prevent a product approval.
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A rare second advisory committee meeting is scheduled for Amylyx’s ALS drug to discuss additional analyses that the company submitted, allowing another glimpse into the FDA’s pre-decision thinking.
The FDA commissioner said several aspects of the advisory committee system should be considered for updates or adjustment. A revamp effort has predated his return trip to the agency.
Confirmation hearing comment suggests FDA Commissioner nominee Robert Califf thinks an overwhelming advisory committee vote should give agency officials pause.