FOOD AND DRUG ADMINISTRATION

Center for Drug Evaluation and Research

ANESTHETIC AND LIFE SUPPORT DRUGS ADVISORY COMMITTEE (ALSDAC)

Holiday Inn, Ballrooms, 2 Montgomery Village Avenue, Gaithersburg, MD

8:00 a.m. Call to Order and Introductions Nathaniel P. Katz, M.D.

Acting Chair, ALSAC

8:20 a.m. Welcome and Introductory Comments Cynthia McCormick, M.D.

Director, Division of Anesthetic,

Critical Care and Addiction

Drug Products (DACADP), FDA

8:35 a.m. Open Public Hearing

9:50 a.m. Introduction to Session I: Bob Rappaport, M.D.

10:00 a.m. Pain Treatment Guidelines Bruce Allen Levy, M.D., J.D.

10:30 a.m. Treatment of Patients with Chronic Pain Russell Portenoy, M.D.

Department of Pain Medicine and Palliative Care

11:00 a.m. Break

11:15 a.m. Opiate Analgesic Trials and Gerald DalPan, M.D.

Drug Development Plans Medical Officer, DACADP, FDA

11:30 p.m. Questions and Discussion

12:30 p.m. Lunch

1:30 p.m. Introduction to Session II Bob Rappaport, M.D.

Opiate Analgesic Use in Pediatric Patients Deputy Director, DACADP, FDA

1:45 p.m. Pediatric Analgesic Use Debra Friedman, M.D.

2:15 p.m. Pediatric Exclusivity and the Pediatric Rule Rosemary Roberts, M.D.

Pediatrics Team, FDA

2:40 p.m. Pediatric Opiate Analgesic Trials Nancy Chang, M.D.

and Development Plans: Case Studies Medical Officer, DACADP, FDA

3:00 p.m. Questions and Discussion

5:30 p.m. Adjourn