Food and Drug Administration

Advisory Committee for Pharmaceutical Science

Pharmacology and Toxicology Subcommittee

June 10, 2003

Briefing Information

Bibliography (HTM) (PDF) (Word)

Drug Development and Regulation in the Age of Pharmacogenomics, Dr. Janet Woodcock, MD (PDF)

Guidance for Industry: Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products (PDF)