Docket Number: FDA-2021-D-0669 Issued by:

Guidance Issuing Office

Center for Drug Evaluation and Research

This Addendum is to be used in close conjunction with ICH S1A Guideline on the Need for Carcinogenicity Studies for Pharmaceuticals, S1B Testing for Carcinogenicity of Pharmaceuticals, and S1C(R2) Dose Selection for Carcinogenicity Studies. The Addendum is complementary to the S1 Guidelines.

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All written comments should be identified with this document's docket number: FDA-2021-D-0669.