1
One Year Post Exclusivity Adverse Event Review as Mandated by the
 Best Pharmaceuticals for Children Act
 Presented at the
 Psychopharmacologic Drugs Advisory Committee
& Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee Meeting
February 2, 2004
Solomon Iyasu, MD, MPH
Hari Cheryl Sachs, MD, FAAP
Division of Pediatric Drug Development
Center for Drug Evaluation and Research
Food and Drug Administration