Food and Drug Administration

Oncologic Drugs Advisory Committee

Pediatric Subcommittee

March 17, 2004

Briefing Information

Coversheet and Table of Contents (HTM) (PDF) (Word)

Points to Consider (HTM) (PDF) (Word)

HHS Report to Congress - Protection for Children in Research (PDF)

April 24, 2001 Interim Rule, Federal Register (HTM) (PDF) (Word)

NIH Policy and Guidelines on the Inclusion of Children (HTM) (PDF) (Word)

The Belmont Report (HTM) (PDF) (Word)

Guidance for Industry - E11 Clinical Investigation of Medicinal Products in the Pediatric Population (PDF)

Guidance for Industry - E6 Good Clinical Practice: Consolidated Guidance (PDF)

Bibliography (HTM) (PDF) (Word)