Food and Drug Administration
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)