Citizen petition review involvement of outside advisors endorsed by CDER's Woodcock.
This article was originally published in The Tan Sheet
Executive Summary
CITIZEN PETITION PROCESS ENHANCEMENT BY INCREASED EXTERNAL PARTICIPATION suggested by FDA Center for Drug Evaluation & Research Director Janet Woodcock, MD, at the Food & Drug Law Institute's annual educational conference in Washington, D.C. Dec. 9. In response to questions regarding the prospective reform of the citizen petition process, Woodcock stated: "Often a good idea, when there really is scientific disagreement amongst parties, is bringing in outside advisors...if it can be done in timely manner."
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