International Conference on Harmonisation; Guidance on S9 Nonclincal Evaluation for Anticancer Pharmaceuticals; availability. Notice

Fed Regist. 2010 Mar 8;75(44):10487-8.

Abstract

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "S9 Nonclinical Evaluation for Anticancer Pharmaceuticals." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The 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 guidance is intended to provide information on internationally accepted recommendations for nonclinical studies to facilitate the development of anticancer pharmaceuticals.

MeSH terms

  • Antineoplastic Agents*
  • Congresses as Topic
  • Drug Approval*
  • Drug Evaluation / standards*
  • Europe
  • Guidelines as Topic*
  • Humans
  • International Cooperation*
  • Investigational New Drug Application*
  • Japan
  • United States
  • United States Food and Drug Administration

Substances

  • Antineoplastic Agents