FDAnews Drug Daily Bulletin
Pharmaceuticals / Research and Development

FDA Reviews Questions on ICH Guidance for Nonclinical Evaluation of Cancer Drugs

Sept. 23, 2016

The FDA is taking public questions and comments relating to implementing a global guidance from 2010 on the nonclinical evaluation of anticancer drugs, also known as the S9 guidance, developed by the International Council for Harmonisation.

Essentially a guidance-for-a-guidance, the draft will be open to public comment for the next 60 days. Comments on the draft will be considered by the FDA and the ICH Safety Implementation Working Group.

Topics addressed include the patient population covered by the S9 guidance, recovery groups in nonclinical studies, development of antibody-drug conjugates, juvenile animal studies, and the need for long-term toxicity studies when pharmaceutical development moves to patients with earlier-stage diseases, according to the FDA.

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