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Quality By Design Pilot Found Unprecedented Manufacturing Quirk For Effient

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Lilly's participation in an FDA manufacturing pilot program designed to maximize efficiency and agility appears to have uncovered an unusual issue that further complicated the lengthy and overdue review of the Effient (prasugrel) NDA - but, serendipitously, may have laid the groundwork for another fortuitous comparison for Effient in its commercial battle with Plavix

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