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PhRMA optimistic about PDUFA/FDA modernization package -- association's Holmer.

This article was originally published in The Tan Sheet

Executive Summary

PHRMA OPTIMISTIC ABOUT ENACTMENT OF "FDA MODERNIZATION"/PDUFA PACKAGE, Pharmaceutical Research & Manufacturers of America President Alan Holmer indicated at an April 15 briefing in Washington, D.C. Holmer noted that Senate Labor Committee ranking Democrat Edward Kennedy (Mass.), HHS Secretary Donna Shalala and the Patients' Coalition -- parties who all have opposed the linkage of FDA reform legislation to reauthorization of the Prescription Drug User Fee Act -- each expressed a recent willingness to "accept consensus or non-controversial FDA modernization items as amendments to PDUFA."

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