Food and Drug Administration

Pediatric Subcommittee
Oncologic Drugs Advisory Committee

November 28, 2001


Application of the 1998 Pediatric Rule to Oncology, Steven Hirschfeld, MD PhD, FDA   [ppt version] [htm version]

Pediatric Ethics and Childhood Cancer Research, Eric Kodish, MD, Rainbow Babies and Childrens Hospital   [ppt version] [htm version]

Review of Developmental Pharmacology, J Steven Leeder, PharmD, PhD, Children's Mercy Hospital and Clinics   [ppt version] [htm version]

Challenges of Pharmacokinetic/Pharmacodynamic Assessments in Pediatric Oncology, Clinton F Stewart, PharmD, St Jude Children's Research Hospital [ppt version] [htm version]

Genetic Variability and Cancer, Mary V Relling [ppt version] [htm version]

Approaches to endpoint validation with Steven Goodman, MD, MHS, PhD  [ppt version] [htm version]

Phase I (Dose-Finding) Trials, Edward L Korn, National Cancer Institute   [pdf version]

Up-Front Phase II Windows in Children with Cancer, Victor M Santana MD  [ppt version] [htm version]

Summary Statements, Peter C. Adamson, MD  [ppt version] [htm version]

Summary Statements, Wayne Rackoff, MD  [ppt version] [htm version]