Food and Drug Administration
September 8, 2004
Briefing Information
Draft Guidance: Clinical Evaluation of Weight-Control Drugs
Table of Contents (HTM) (PDF) (Word)
August 7, 2004 Cover Memorandum From FDA (HTM) (PDF) (Word)
Draft Guidance: Guidance for the Clinical Evaluation of Weight-Control Drugs (PDF)
FDA Approved Obesity Drugs (HTM) (PDF) (Word)
Bibliography (HTM) (PDF) (Word)
January 26, 2004 Federal Register Notice, Request for Comments on a Draft Guidance on the Clinical Evaluation of Weight-Control Drugs (PDF)
Public Comments (PDF)
Guidance for Industry: The Extent of Population Exposure to Assess Clinical Safety: For Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions (PDF)
Guidance for Industry: Premarketing Risk Assessment (PDF)