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Drug Approvals After First-Cycle Review Decline, Parexel Report Finds

Executive Summary

FDA's Center for Drug Evaluation & Research cleared fewer NDAs after one review in 2005 than it did the previous year, according to Parexel International's Bio/Pharmaceutical R&D Statistical Sourcebook 2007/2008

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CDER Takes Steps To Meet First-Cycle Review Goals Of GRMP Guidance

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