Pediatric Advisory Subcommittee Meeting

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FDA/Center for Drug Evaluation and Research

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