Food and Drug Administration

Oncologic Drugs Advisory Committee

Pediatric Oncology Subcommittee

July 15, 20032


Introduction and Overview, Dr. Steven Hirschfeld, MD PhD, FDA (HTM) (PPT)

Postmarketing Safety Evaluation of Approved Drugs and Risk Management, Dr. Victor Raczkowski, MD, MS, FDA (HTM) (PPT)

Updating Information in the Approved Label for 6-Mercaptopurine: Introduction, Dr. Lawrence Lesko, PhD, FCP, FDA (HTM) (PPT)

TPMT Pharmacogenetics, Dr. Richard Weinshilboum, MD, Mayo Medical School-Mayo Clinic, Rochester, MN (HTM) (PPT)

TPMT: Clinical Utility in Childhood ALL, Dr. Howard McLeod, Washingtion University, St. Louis (HTM) (PPT)

TPMT Assessment, 6-MP Dosing and Childhood ALL, Dr. Naomi Winick, MD (HTM) (PPT)

Overview of Research Oversight: U.S. Perspective, Dr. Leslie Ball, MD, FAAP, Dept. Health & Human Services (HTM) (PPT)

Approval of Clinical Studies Involving Children in the UK, Dr. Hugh Davies, MD (HTM) (PPT)

Overcoming Challenges in Pediatric Oncology Product Development: Regulatory Oversight of Multi-National Clinical Studies, Ursula Kern, Federal Institute of Drugs and Medical Devices, Germany (HTM) (PPT)