Food and Drug Administration

Anti-Infective Drugs Advisory Committee

Pediatric Subcommittee

February 3-4, 2004

Briefing Information

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

Overview (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)