US FDA Advisory Committee Reboot (Part I): Open Public Meeting A Place To Start?
Executive Summary
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.
You may also be interested in...
US FDA Advisory Committee Members Say Votes Should More Directly Affect Agency Decisions
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.
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.
US FDA Advisory Committee Reboot (Part III): Asking The Right Questions
Rethinking the voting and discussion questions to advisory committees may be one way to ensure FDA gets the advice it needs.