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CDER Conversations

CDER Conversation: FDA’s Final Guidance on Carcinogenicity Testing of Pharmaceuticals

FDA has issued a final guidance, “S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals; International Council for Harmonization; Guidance for Industry,” which introduces a comprehensive and integrative weight of evidence approach to assessing human carcinogenic (or having the potential to cause cancer) risk in drugs. This guidance is part of FDA’s work to reduce the use of animals in research for certain drugs.

The guidance, which is the result of a collaboration between the agency and the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), outlines an approach that, in certain cases, could determine that a two-year rat study is not necessary to assess the carcinogenic risk of a drug.

In this CDER Conversation, we speak with Timothy McGovern, PhD, about the guidance and what it means for patients, industry, and other stakeholders in drug development. Tim is the associate director of pharmacology and toxicology in FDA’s Center for Drug Evaluation and Research Office of New Drugs' Immediate Office.

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