Exclusivity AND pediatric exclusivity in BOTH the US and EU

Orphan Drug Exclusivity and Pediatric Exclusivity • Identify and discuss existing and proposed regulations regarding orphan drug exclusivity AND pediatric exclusivity in BOTH the US and EU. • Develop a regulatory strategy for orphan drug designation and pediatric development in BOTH regions for the following treatment: o The novel secondary treatment for iron overload (not existing iron chelator therapies) due to the treatment of beta thalassemia o Timelines for specific submissions in both regions (e.g., IND, Orphan Drug Designation Application, and Pediatric Development Plant in the US) must be suggested