AGENDA

Issue: Clinical Development of Products

for Drooling in Neurologically Impaired Children

8:00 a.m. Call to Order/Introductions

P. Joan Chesney, M.D., Chair, Pediatric Advisory Subcommittee

Conflict of Interest Statement

Jayne E. Peterson, R.Ph., J.D., Subcommittee Executive Secretary

8:05 a.m. Welcome/Background Information and Overview

Dianne Murphy, M.D., Associate Director of Pediatrics, Center for Drug

Evaluation and Research (CDER), FDA

8:10 a.m. Review of Meeting Agenda/Introduction to the Issues

John V. Kelsey, D.D.S., Clinical Team Leader, Division of Dermatologic

and Dental Drug Products (DDDDP), FDA

8:20 a.m. Pharmacologic Control of Drooling

Lisa Mathis, M.D., Medical Officer, DDDDP, FDA

8:35 a.m. Questions from the Subcommittee

8:45 a.m. Ethical Issues in Pediatric Research: Antimuscarinics to Control the

Medical and Psychosocial Complications of Drooling

Benjamin Wilfond, M.D., Office of Bioethics and

Special Populations Research, Department of Clinical Bioethics , National Institutes

of Health (NIH)

9:00 a.m. The Medical/Surgical Management of Drooling

Maria Pena, M.D., Department of Otolaryngology, Children’s National Medical

Center

9:15 a.m. Assessment/Methods for Capturing Information from the Patient

Ross Hays, M.D., Children’s Hospital, Seattle, Washington

9:30 a.m. Questions from the Subcommittee

 

AGENDA (cont.)

Issue: Clinical Development of Products

for Drooling in Neurologically Impaired Children

9:40 a.m. American Academy of Pediatrics (AAP) Perspective

Scott Stiefel, M.D., Assistant Professor, Department of

Pediatrics and Child and Adult Psychiatry, University of Utah

9:50 a.m. The Scope of the Problem

Murray Goldstein, D.O., Medical Director, United Cerebral Palsy Research and

Educational Foundation

10:00 a.m. Parent/Caregiver Perspective

Ms. Belinda Hurlburt

10:10 a.m. Questions from the Subcommittee

10:15 a.m. Break

10:30 a.m. Open Public Hearing

(**30 minutes allocated unless public participation does not last that long.)

11:00 a.m. Presentation of Issues

John V. Kelsey, D.D.S., DDDDP, FDA

Subcommittee Discussion of Issues/Questions

12:00 noon Lunch

1:00 p.m. Continuation of Subcommittee Discussion of Issues/Questions

2:50 p.m. Closing Remarks

Dianne Murphy, M.D.

3:00 p.m. Adjournment