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Generic Drugs Review Pathway Regulation

Generic Drugs: First-Cycle Review Times Improve, But Hundreds Of ANDAs Still Pending

  • Analysis

Executive Summary

US FDA cut first-cycle review time 46% between fiscal year 2013 and FY 2015, but more than 900 ANDAs still awaited review by end of 2016.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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