Clinical Research Solutions
Orphan Drug Designations in the US and EU
What is an Orphan Drug Designation? The Orphan Drug Designation (ODD) program in both the United States (U.S.) and European Union (E.U.) qualifies sponsors to receive potential incentives to develop...
Clinical Research Solutions
FDA Revises Review Timeline Due to Increasing Number of Orphan Drug Applications
FDA Revises Review Timeline Due to Increasing Number of Orphan Drug Applications: In 1983 Congress passed the Orphan Drug Act, which created FDA’s Orphan Drug Designation (ODD) program. The goal of...