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Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter 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.
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:
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.