Pediatric Advisory Subcommittee of the Anti-Infective Drugs Advisory Committee

Food and Drug Administration

Center for Drug Evaluation and Research

Advisory Committee Conference Room, Rm. 1066, 5630 Fishers Lane, Rockville, MD.

Development of Antiretroviral Drugs in HIV-Infected and HIV-Exposed Neonates Younger than four weeks of age, and Update to the Committee on Adverse Event Reporting plan, and Pediatric Initiatives within the Agency

Agenda for March 3, 2003

Issue: Antiretroviral Drug Development in HIV-Infected and HIV-Exposed Neonates

8:00 Call to Order, Introductions: Joan P. Chesney, M.D., Chair

Meeting Statement: Thomas H. Perez, R.Ph., M.P.H., Executive Secretary

Opening Comments: Dianne Murphy, M.D.,
Director, Office of Pediatric Therapeutics

8:20 State of the Art: Perinatal Transmission Lynne Mofenson, M.D.

8:50 Ethics of Neonatal Research John Sever, M.D.

9:10 FDA Perspective Linda Lewis, M.D.

9:30 Questions on Presentations

9:35 Break

9:50 Open Public Hearing

10:50 Discussion of Questions

12:00 Lunch

1:00 Discussion of Questions

2:15 Break

Issue: Pediatric Update

2:30 Overview: Division of Pediatric Drug Development

Office of Pediatric Therapeutics Dianne Murphy, M.D.

2:45 Medwatch Office of Drug Safety

Adverse Event Reporting Solomon Iyasu, M.D.

4:00 Division of Pediatric Drug Development - Update Shirley Murphy, M.D.

4:20 New Exclusivity / Rule Statistics Terrie Crescenzi, R.Ph.

4:45 Adjourn