FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)

 

Endocrinologic and Metabolic Drugs

Advisory Committee Meeting

September 8, 2004

 

Holiday Inn, Versailles Ballrooms, 8120 Wisconsin Ave, Bethesda Maryland

           

 

FDA Background Package

 

 

Table of Contents

 

 

Tab 1       Division Memo

 

Tab 2       Draft Agenda

 

Tab 3       FDA Draft guidance document “Guidance for the Clinical Evaluation of Weight-Control Drugs”

 

Tab 4       FDA approved obesity drugs

 

Tab 5       Article: National Trends in Antiobesity Medication Use; Randall Stafford, M.D., Ph.D., and David C. Radley, BA

 

Tab 6       FR Notice 69; January 26, 2004; Request for Comments on Draft Guidance on the Clinical Evaluation of Weight-Control Drugs

 

Public comments submitted to Docket No. 2003-0570,

In response to FR Notice 69

 

Tab 7       ICH -E1A guidelines March 1995

 

Draft Guidance for Industry Pre-marketing Risk Assessment