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Reconstructing Advisory Committees: FDA Conflict of Interest Policy Will Pose Challenges for Drug Sponsors

This article was originally published in RPM Report

Executive Summary

Drug sponsors soon will have another hurdle to overcome at advisory committee meetings: significant turnover in the experts asked to consider the approvability of their products. The new policy will help FDA quiet critics of the agency's advisory committee system, but it will also create more noise around the drug approval process.

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FDA's Advisory Committee Oversight & Management Staff is charged with developing policies and guidelines for the 30 expert panels across the agency. The staff has been busy developing four separate guidance documents that revamp the advisory committee system. Here are the principle players in that effort.

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