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US FDA Advisory Committee Reboot (Part II): The Right Balance For Conflicts Of Interest

Executive Summary

After back-and-forth tinkering with CoI restrictions, CDER is still finding it challenging to seat the right experts. Maybe more realistic guidelines are needed.

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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.

US FDA Advisory Committee Reboot (Part I): Open Public Meeting A Place To Start?

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.

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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