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

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.