US FDA Advisory Committee Reboot (Part III): Asking The Right Questions

 
• By Kate Rawson

Rethinking the voting and discussion questions to advisory committees may be one way to ensure FDA gets the advice it needs.

US FDA Advisory Committee Reboot (Part III): Asking The Right Questions (Alamy)
• Source: Alamy

In rethinking the Center for Drug Evaluation & Research’s use of advisory committees, CDER Director Patrizia Cavazzoni says her goal is to encourage “thoughtful input” from the agency’s external experts in response to “thoughtful questions” from review teams about the benefits and risks of a particular product.

“We need to give some thought on how to get back to the fundamental reasons for advisory committees, which is...

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