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Guidance Documents/Guidance-Document/M3(R2)Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals: Questions and Answers

M3(R2)Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals: Questions and Answers

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

March 13, 2013

April 24, 2020

Center for Drug Evaluation and Research

04bea7cb-30a1-49e6-94c9-51131e6004d7

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