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Advisory committees under review

This article was originally published in The Tan Sheet

Executive Summary

The Center for Drug Evaluation & Research will review its advisory committee meeting system over the next year to establish best practices surrounding the process, FDA announces May 5. The internal assessment, led by senior management from CDER's Advisors & Consultants Staff, is part of FDA's broader initiative to modernize management of the new drug review process. The evaluation will look at the process for nominating members and choosing consultants, developing competing products lists, screening for conflicts of interest and the role of special government employees outside of advisory committee meetings. The advisory committee system has been a topic of recent public scrutiny. In January, Steve Nissen (Cleveland Clinic Foundation) criticized committees for lacking the means and courage to properly advise FDA on issues of drug safety...





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