FDA center launches internal assessment

"FDA closer to a decision on RFID labels"

The Food and Drug Administration's Center for Drug Evaluation and Research (CDER) is launching an internal assessment of its Advisory Committee Meeting system to establish best practices for conducting the process.

The assessment is part of the FDA’s effort to modernize managing the new drug review process.

“The idea is to identify best practices and adopt them centerwide to improve the consistency and predictability of the work we do,” Dr. Scott Gottlieb, deputy commissioner for medical and scientific affairs, said in a statement.

Senior managers from the CDER Advisors and Consultants Staff will look at current practices, including the processes for nominating members, choosing consultants with expertise specific to the meeting topic, developing competing products’ lists, screening for conflicts of interest and using special government employees outside an advisory committee meeting.

In addition, the review will involve meetings administration, such as development of the agenda, preparation of background materials and presentations, and crafting questions to the committee for review, discussion and voting.

Currently there are 16 standing advisory committees operating in CDER. The review will begin immediately and is expected to take one year.

About the Author

David Hubler is the former print managing editor for GCN and senior editor for Washington Technology. He is freelance writer living in Annandale, Va.


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