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GUIDANCE DOCUMENT

S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use June 2012

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2008-D-0178
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This guidance combines and replaces two ICH guidances, S2A Specific Aspects for Regulatory Genotoxicity Tests for Pharmaceuticals (ICH S2A guidance) and S2B Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals (ICH S2B guidance). The purpose of the revision is to provide guidance on optimizing the standard genetic toxicology battery for prediction of potential human risks, and on interpreting results, with the goal of improving risk characterization for carcinogenic effects that have their basis in changes in the genetic material. The revised guidance describes internationally agreed-upon standards for follow-up testing and interpretation of positive results in vitro and in vivo in the standard genetic toxicology battery, including assessment of nonrelevant findings. This guidance is intended to apply only to products being developed as human pharmaceuticals.

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All written comments should be identified with this document's docket number: FDA-2008-D-0178.

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