DRAFT AGENDA
Pediatric Advisory Subcommittee Meeting
A Subcommittee of the Anti-Infective Drugs Advisory Committee
Center for Drug Evaluation and Research (CDER), Food and Drug Administration
April 23, 1999
[List of Particpants]
8:30 a.m. Call to Order
P. Joan Chesney, M.D., Subcommittee Chair
Conflict of Interest Statement
Rhonda W. Stover, RPh., Executive Secretary
8:35-8:45 Welcome and Introduction to FDA Pediatric Drug Development Activities
Murray Lumpkin, M.D.
Deputy Center Director, Office of Review Management, CDER, FDA
8:45-8:55 Pediatric Regulatory Initiatives History
Dianne Murphy, M.D.
Associate Director of Pediatrics, CDER, FDA
8:55-9:25 The Pediatric Rule
Rosemary Roberts, M.D.
Medical Officer, Pediatrics Team, CDER, FDA
9:25-9:45 The Pediatric Rule and Exclusivity Interactions
Dianne Murphy, M.D.
9:45-10:00 Lessons Learned from Pediatric Development Programs
Karen Weiss, M.D
Director, Division of Clinical Trial Design and Analysis, Office of Therapeutics,
Center for Biologics Evaluation and Research (CBER), FDA
10:00-10:45 Questions and Comments from the Advisory Subcommittee
10:45-11:00 Break
11:00-11:15 American Academy of Pediatrics
Daniel Notterman, M.D., FAAP
Department of Molecular Biology, Princeton University
11:15-11:30 Pharmaceutical Research and Manufacturers of America (PHRMA)
Michael Horan, M.D., Sc.M.
Associate Vice President for Clinical Affairs, PHRMA
11:30-11:45 Pediatric Health Information System
Dave Grinder, M.S.
Pediatric Pharmacy Advocacy Group
11:45-12:00 Elizabeth Glaser Pediatric AIDS Foundation
Timothy Westmoreland, Esq.
Public Policy Representative, Pediatric AIDS Foundation
12:00-1:00 Open Public Hearing
1:00-2:00 Lunch
2:00-2:30 Priority List
Leanne Cusumano, Esq.
Regulatory Policy Staff, CDER, FDA
2:30-2:45 Comments
2:45-3:00 Waivers
Rosemary Roberts, M.D.
3:00-3:15 Comments
3:15-3:45 Timing of Initiation of Pediatric Studies
Monica Roberts, M.D.
Medical Officer, Division of Anesthetic, Critical Care, and Addiction Drug Products, CDER, FDA
3:45-4:15 Comments
4:15-4:30 Future Consideration
Dianne Murphy, M.D.
4:30-4:45 Comments
4:45-4:50 Closure
4:50 p.m. Adjourn
Last update: July 7, 2005 |