Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee

Food and Drug Administration

Center for Drug Evaluation and Research

ACS Building, 5630 Fishers Lane, Rockville, MD

Pediatric Labeling for Oncology Products

Agenda for March 4, 2003


8:30 Call to order and Introduction Victor M. Santana, M.D., Chair

Conflict of Interest Thomas H. Perez, M.P.H., Executive Secretary

Welcome Richard Pazdur, M.D.,

Director, Division of Oncology Drug Products

8:45 History of Pediatric Labeling Steven Hirschfeld, M.D., Ph.D., Medical Officer

Division of Oncology Drug Products

9:05 Case Studies of Pediatric Submissions for Oncology Products

Anne Zajicek, Pharm.D., M.D.

Ramzi Dagher, M.D.

Steven Hirschfeld, M.D., Ph.D.

Susan Honig, M.D.

Alla Shapiro, M.D.

9:50 Committee Questions to the Presenters

10:10 Break

10:25 Open Public Hearing Edward J. Allera, B.S., J.D.,

Buchanan & Ingersoll

11:25 Discussion of Questions to the Committee

12:00 Lunch

1:00 Discussion of Questions to the Committee

3:15 Chairmanís Summary of Discussion

3:30 Adjourn