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GUIDANCE DOCUMENT

S2B Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals November 1997

Final
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

Two fundamental areas in which harmonization of genotoxicity testing for pharmaceuticals is considered necessary are the scope of this guidance: (1) Identification of a standard set of tests to be conducted for registration. (2) The extent of confirmatory experimentation in in vitro genotoxicity tests in the standard battery. Further issues that were considered necessary for harmonization can be found in the ICH guidance S2A Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals. The two ICH guidances on genotoxicity complement each other and therefore should be used together as ICH guidance principles for testing of a pharmaceutical for potential genotoxicity.


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Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.