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