FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)
Call to Order and Introductions Glenn Braunstein, M.D.
Acting Chair, Endocrinologic and Metabolic
Drugs Advisory Committee, EMDAC
Conflict of Interest Statement LCDR Dornette Spell-LeSane, M.H.A., NP-C
Executive Secretary, EMDAC
Welcome and Introductory Comments David Orloff, M.D.
Division of Metabolic and Endocrine
Drug Products (DMEDP), FDA
The FDA draft guidance document entitled:
“GUIDANCE for the Clinical Evaluation of Weight-Control Drugs”
The Regulatory History of Weight-Loss Drugs Eric Colman, M.D.
Medical Team Leader
Current Status of Weight-Loss Drugs TBA
9: 45 Patterns of Weight-Loss Drug Use Laura A. Governale, Pharm.D., MBA Drug Utilization Specialist, Team Leader
Division of Surveillance, Research and Communication Support
Office of Drug Safety (ODS)
FDA Presentation Continued
The 1996 FDA Draft Guidance Document David Orloff, M.D.
Open Public Hearing
Questions from the Committee
Charge to the Committee David Orloff, M.D.