After the United States issued pediatric drug study requirements, the European Union (EU) passed a regulation that created major changes to clinical studies for pediatric patients. A significant step toward safer dosing for children, the EU guidance opens new questions about pediatric drug development. Quintiles regulatory experts Dr. Raj Kishore and Dr. Edward Tabor review the major provisions of the EU regulation and compare it to its US counterpart. Of particular interest: Exclusivity incentives for conducting studies in pediatric patients, including orphan indications.