Food and Drug Administration

Oncologic Drugs Advisory Committee

Pediatric Subcommite

October 9, 2003

Briefing Information

Index (HTM) (PDF) (Word)

Best Pharmaceuticals for Children Act, 2002 (PDF)

Bibliography (HTM) (PDF) (Word)

Off Patent Oncology Drugs (PDF)

Off Patent Oncology Drugs--Addendum (HTM) (PDF) (Word)

Approved Oncology Drugs With Pediatric Labeling (PDF)

Cancer Pharmacology in Infants and Young Children Workshop (HTM) (PDF) (Word)

Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products - General Considerations (PDF)

Guidance for Industry: Exposure-Response Relationships - Study Design, Data Analysis, and Regulatory Applications (PDF)