Prescription Drug User Fee Act Patient-Focused Drug Development; Announcement of Disease Areas for Meetings Conducted in Fiscal Years 2016-2017

Résumé

The Food and Drug Administration (FDA or Agency) is announcing the selection of disease areas to be addressed during fiscal years (FYs) 2016-2017of its Patient-Focused Drug Development Initiative. This initiative is being conducted to fulfill FDA's performance commitments under the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). This effort provides a more systematic approach under PDUFA V for obtaining the patients' perspective on disease severity and currently available treatments for a set of disease areas. FDA selected these disease areas based on a careful consideration of the public comments received after publication of a preliminary list of disease areas in the Federal Register on October 8, 2014.