S2A Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals
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.
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:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.