Food and Drug Administration

Center for Drug Evaluation and Research


Oncologic Drugs Advisory Committee Meeting

May 3-4, 2004


Briefing Material: May 4, 2004

PM session CRC End Points



Table of Contents:


Memo from: Richard Pazdur, M.D.

Director, Division of Oncology Drug Products


Tab 1: Johnson, John R., Williams, Grant & Pazdur, Richard. (2003) Endpoints and United States Food and Drug Administration: Approval of Oncology Drugs. Journal of Clinical Oncology, 21 (7), pp 1404-1411.


Tab 2: Summary of November 12, 2003 Colorectal Cancer Endpoints Workshop