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