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GUIDANCE DOCUMENT

S1B Testing for Carcinogenicity of Pharmaceuticals February 1998

Final

Docket Number:: FDA-1996-D-0010
Issued by:: Guidance Issuing Office

Center for Drug Evaluation and Research

Center for Biologics Evaluation and Research

This document provides guidance on approaches for evaluating the carcinogenic potential of pharmaceuticals.

Submit Comments

Submit Comments Online

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-1996-D-0010.

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