Food and Drug Administration
Pediatric Subcommittee
February 3-4, 2004
Briefing Information
Table of Contents (HTM) (PDF) (Word)
Guidance for Industry: Medical Imaging Drug and Biological PRoducts, Part 1: Conducting Safety Assessments (PDF)
Guidance for Industry: Medical Imaging Drug and Biological Products, Part 2: Clincal Indications (PDF)
Guidance for Industry: Medical Imaging Drug and Biological Products, Part 3: Design, Analysis, and Interpretation of Clinical Studies (PDF)
Bibliography (HTM) (PDF) (Word)
Paxil® (Paroxetine Hydrochloride) Tablets and Oral Suspension Label (PDF)
Celexa™ (Citalopram Hydrobromide) Tablets and Oral Suspension (PDF)
Pravachol® (Pravastatin Sodium) Tablets (PDF)
Navelbine (Vinorelbine Tartrate) Injection (PDF)