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Guidance Documents/Guidance-Document/Guidance for Review Staff and Industry Good Review Management Principles and Practices for PDUFA Products

Guidance for Review Staff and Industry Good Review Management Principles and Practices for PDUFA Products

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

April 1, 2005

December 18, 2019

Center for Drug Evaluation and Research

2063ec1b-8811-4dd6-88f7-f0849ff947a9

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