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GUIDANCE DOCUMENT

S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals Guidance for Industry November 2022

Download the Final Guidance Document Read the Federal Register Notice
Final Level 1 Guidance
Docket Number:
FDA-2021-D-0669
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This Addendum applies to all pharmaceuticals that need carcinogenicity testing as described in  ICH S1A.  For biotechnology-derived pharmaceuticals, refer to the ICH guidance for industry S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (May 2012)).

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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-2021-D-0669.

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