U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. S2B Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

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

Final
Docket Number:
FDA-1997-D-0199
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.


Submit Comments

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:

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-1997-D-0199.

Back to Top