Subject :US-FDA revised ICH Guidance:M3(R2) Nonclinical Safety Studies for Conduct of CT
FDA issues revised ICH Guidance: "M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals."
Discusses the types of nonclinical studies, their scope and duration, and their relationship to the conduct of human clinical trials.
Federal Register listing: http://edocket.access.gpo.gov/2010/pdf/2010-1027.pdf
Guidance document: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073246.pdf