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First Cycle Approval Rate Tops 50% For 2006 NMEs; Merck Hits 100%

Executive Summary

Merck skillfully navigated FDA's approval process in 2006, receiving all five of its new molecular entity and novel biologic approvals after only a single review cycle

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NME Slump Continues: FDA Clears 18 Novel Drugs In 2006, Same As 2005

FDA's final approval tally of new molecular entities in 2006 is almost a 25-year low, despite early signs that the agency was on pace to best last year's final count of NME approvals

User Fee Hike Will Give Sponsors Clarity On Label, Postmarketing Discussions

As part of its recommendations for the renewal of the user fee program, FDA is proposing refinements to its "74-day letters" to give sponsors a more detailed schedule of how the application review will proceed

First-Cycle Approvals May Rise For Second Consecutive Year – Parexel Report

First-cycle approvals by FDA's Center for Drug Evaluation & Research may continue to rise for a second consecutive year, according to Parexel's Bio/Pharmaceutical R&D Statistical Sourcebook 2006/2007

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