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GUIDANCE DOCUMENT

M3(R2)Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals: Questions and Answers March 2013

Final
Docket Number:
FDA-2008-D-0470
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

Although the ICH M3(R2) guidance is still in its early phases of the implementation, the complexity of the guidance, its broader scope, and numerous changes in recommendations from the M3(R1) guidance have generated questions that have an impact on its successful implementation. This question and answer (Q&A) document is intended to clarify the key issues. The Steering Committee has endorsed the establishment of an M3(R2) Implementation Working Group (IWG), which is currently working on the development of Q&As.


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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2008-D-0470.