This post was written by Paul Sheives.

FDA has released a new guidance from the International Conference on Harmonization (ICH) entitled “S9 Nonclinical Evaluation for Anticancer Pharmaceuticals.” The guidance is intended to assist in the design of an appropriate program of nonclinical studies for the development of anticancer pharmaceuticals. The guidance seeks to help sponsors identify the type and timing of nonclinical studies in relation to the development of anticancer pharmaceuticals, and addresses both non-clinical studies conducted to evaluate safety and clinical trial design and marketing.