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GUIDANCE DOCUMENT

S1B Testing for Carcinogenicity of Pharmaceuticals February 1998

Download the Final Guidance Document Read the Federal Register Notice
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.

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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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