Food and Drug Administration

Endocrinologic and Metabolic Drugs Advisory Committee

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Draft Guidance: Clinical Evaluation of Weight-Control Drugs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Draft Guidance: Guidance for the Clinical Evaluation of Weight-Control Drugs (PDF)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January 26, 2004 Federal Register Notice, Request for Comments on a Draft Guidance on the Clinical Evaluation of Weight-Control Drugs (PDF)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)