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Guidance Issuing OfficeCenter 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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
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All written comments should be identified with this document's docket number: FDA-1997-D-0199.