Rare/Orphan Diseases and the African American Community
How do we improve outcomes for an uncommon healthcare challenge in a community challenged with common healthcare issues? The Orphan Drug Act defines a rare disease as a disease or condition that...
Regulatory Sciences
Competition Between Orphan Drug Sponsors – Good for Patients, Strategic Complexities for Sponsors
The regulations developed by the FDA for implementing the Orphan Drug Act contain a number of features that are intended to maximize benefits to the orphan disease patient population, but which pose...