Zdrowie i gospodarka · 17/02/2009

International Conference on Harmonisation; Draft Guidance on S9 Nonclinical Evaluation for Anticancer Pharmaceuticals; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "S9 Nonclinical Evaluation for Anticancer Pharmaceuticals." The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance provides recommendations for nonclinical studies for the development of pharmaceuticals, including both drugs and biotechnology-derived products, intended to treat patients with advanced cancer. The recommendations describe the type and timing of nonclinical studies to support an investigational new drug application (IND) and the submission of a new drug application (NDA) or biologics license application (BLA). The draft guidance is intended to provide information on internationally accepted recommendations for nonclinical studies to facilitate the development of anticancer pharmaceuticals.