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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 February 2013

Final
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.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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 comments should be identified with the title of the guidance.