Food and Drug Administration
Anti-Infective Drugs Advisory Committee
March 3, 2003
Prevention of Mother-to-Child HIV Transmission in the US and Globally, Dr.
Lynne Mofenson, MD, NIH (HTM) (PPT)
Ethics of Neionatal Research, Dr. John Sever, MD PhD, Geo. Washington Univ.
Ctr. (HTM) (PPT)
HIV Drug Development in Neonates - What Now?, Dr. Linda Lewis, MD, FDA (HTM)
Questions for Discussion - HIV Drug Development in Neonates (HTM)
Pediatrics Update, Dr. Dianne Murphy, MD, FDA (HTM)
Overview of Postmarketing Safety Surveillance in FDA (For Drugs and Biologics),
Min Chen, MS, RPh, FDA (HTM) (PPT)
Adverse Event Tracking as Mandated by the Best Pharmaceuticals for Children
Act, Dr. Solomon Iyasu, FDA (HTM) (PPT)
Division of Pediatric Drug Development, Dr. Shirley Murphy, MD, FDA (HTM)
Statistical Update, Terrie Crescenzi, RPh, FDA (HTM)