Food and Drug Administration
Pediatric Subcommite
October 9, 2003
Briefing Information
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)