S9 Nonclinical Evaluation for Anticancer Pharmaceuticals-Questions and Answers; International Council for Harmonisation; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled ``S9 Nonclinical Evaluation for Anticancer Pharmaceuticals--Questions and Answers.'' The draft questions and answers (Q&As) guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft Q&As guidance provides recommendations for nonclinical studies for the development of pharmaceuticals, including both small molecule and biotechnology- derived products, intended to treat patients with cancer. The Q&As are intended to provide additional clarity for topics discussed in the ICH guidance entitled ``S9 Nonclinical Evaluation for Anticancer Pharmaceuticals'' (S9 guidance).