Issue Date: November 2, 2022
Issued by: Center for Drug Evaluation and Research
Topic(s): ICH-Safety
Status: Final
S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals: Guidance for Industry
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)).
Download the Guidance Document
