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US FDA Advisory Committee Formats Can Spur Unhealthy Dynamics – Califf

 
• By Sarah Karlin-Smith

FDA commissioner is thinking about how advisory panel interactions might improperly influence meeting outcomes as the agency undertakes a 'stem to stern' review of the process.  

five people with same "thinking" bubble
FDA thinking about how to curtail problematic group dynamics during advisory panels. • Source: Shutterstock

US Food and Drug Administration Commissioner Robert Califf is raising concerns about how current advisory committee formats can influence meeting outcomes, and perhaps not for the better, as the agency undergoes a “stem to stern review” of the process for making key recommendations on drug approvals.

“If you get a bunch of people that get a book this thick and then show up in a room at eight o'clock in the morning, and they can't talk...

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