FDA Orphan Approval Flexibility Remains Steady As Pressure Increases

It appears FDA has not wavered from, or increased, its rate of using flexibility toward orphan drugs four years after a landmark analysis confirmed the long-held agency belief.

Frank Sasinowski, a director at Hyman, Phelps and McNamara, and colleagues showed that from July 2010 to June 2014, about two-thirds of FDA orphan drug approvals used some agency flexibility in the requirements to prove effectiveness