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

 
• By Kate Rawson
  
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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.

open sign on door (Alamy)
• Source: Alamy

The Center for Drug Evaluation & Research’s comprehensive review of the advisory committee process offers an opportunity for industry to weigh in on possible improvements, starting with how external experts are vetted for membership as well as ideas to improve the clarity and utility of the questions that are asked at the end of the meeting.

CDER Director Patrizia Cavazzoni announced plans to improve the advisory committee process during the Biotechnology Innovation Organization’s recent annual meeting....

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