Joint Meeting of the Nonprescription Drugs Advisory Committee

and the

Endocrinologic and Metabolic Drugs Advisory Committee

January 23, 2006




Table of Contents



1.                 Draft Issues for Discussion

2.                 Article: “Anorectics on Trial: A Half Century of Federal Regulation of Prescription Appetite
Suppressants”; Annals of Internal Medicine

3.                 Clinical Review of Safety and Efficacy; Division of Metabolism and Endocrinology Products

4.                    Memo from the Division of Pediatric Drug Development

5.                 Statistical Review; Division of Biometrics II

6.                 Amended Statistical Review, Division of Biometrics II

7.                 Label Comprehension Review; Division of NonPrescription Clinical Evaluation

8.                 Clinical Review of the Actual Use Study; Division of NonPrescription Clinical Evaluation

9.                 Appendix: The NIH Practical Guide; Identification, Evaluation and Treatment of Overweight
and Obesity in Adults