Pediatric Subcommittee
of the
Anti-Infective Drugs Advisory Committee
Center for Drug Evaluation and Research
Food and Drug Administration
ACS Conference Room, Room 1066, 5630 Fishers Lane, Rockville, MD
March 3, 2003
DRAFT AGENDA
Issue: Antiretroviral Drug Development in HIV-infected and HIV-exposed Neonates
8:00 Welcome/Introductions
8:20 State of the Art/Perinatal Transmission
8:50 Ethics of Neonatal Research
9:10 FDA Perspective
9:30 Presentation of Questions
9:35 Break
9:50 Open Public Hearing
10:50 Discussion
12:00 Lunch
1:00 Discussion
2:15 Break
Issue: One-Year Post-Pediatric Exclusivity Adverse Event Reporting
2:30 Office of Pediatric Therapeutics, BPCA [Sec 6].
2:35 Adverse Events Reporting, BPCA [Sec 17]
2:40 Exclusivity Process
2:45 Overview of FDA’s Adverse Events Reporting System
3:00 One-Year Post-Pediatric Exclusivity Adverse Events Reporting Plan
3:15 Adverse Events Report: Example
3:25 Questions and Answers
3:45 Exclusivity/Rule Update
4:45 Adjourn