S2A Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals April 1996
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter 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.
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
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-1994-D-0134.