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GUIDANCE DOCUMENT

S2A Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals April 1996

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-1994-D-0134
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

Guidelines for the testing of pharmaceuticals for genetic toxicity have been established in the European Community (EEC, 1987) and Japan (Japanese Ministry of Health and Welfare, 1989). FDA's Centers for Drug Evaluation and Research and Biologics Evaluation and Research (CDER and CBER) currently consider the guidance on genetic toxicity testing provided by FDA's Center for Food Safety and Applied Nutrition (58 FR 16536, March 29, 1993) to be applicable to pharmaceuticals.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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

All written comments should be identified with this document's docket number: FDA-1994-D-0134.

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