FDA Guidance for Industry: M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
Title:
FDA Guidance for Industry: M3(R2) Nonclinical Safety Studies
for the Conduct of
Human Clinical Trials and
Marketing Authorization for
Pharmaceuticals
Origin/Publisher:
FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073246.pdf
Content:
The purpose of this document is to recommend international standards for, and promote harmonisation of, the nonclinical safety studies recommended to support human clinical trials of a given scope and duration and marketing authorization.