Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use

Guidance for Industry: S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use (PDF - 428KB)
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM074931.pdf?source=govdelivery