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PhRMA optimistic about enactment of PDUFA/FDA modernization package -- Holmer.

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 (D-Mass.), HHS Secretary Shalala and the Patients' Coalition -- parties who have all opposed the linkage of FDA reform legislation to reauthorization of the Prescription Drug User Fee Act -- have each expressed a recent willingness to "accept consensus or non-controversial FDA modernization items as amendments to PDUFA."

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