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CDER 21st Century Review
A six-step process that involves teamwork and collaboration across disciplines for better and more efficient management of the review process. Click on each image to view the guidance documents below.
Guidance for Review Staff and Industry:Good Review Management Principles and Practices for PDUFA Products (GRMP). CDER 21st Century Review Process Desk Reference Guide. PDUFA Reauthorization Performance Goals and Procedures for Fiscal Years 2013 Through 2017.
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