FDA selects narcolepsy as one disease area for patient-focused drug development
American Academy of Sleep Medicine
Friday, April 19, 2013
In a statement published in the Federal Register on April 11, the Food and Drug Administration announced that narcolepsy was selected as one of the disease areas to be addressed during the first three years of Patient-Focused Drug Development. This five-year initiative is being conducted to fulfill the FDA’s performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). FDA has committed to obtain the patient perspective on 20 disease areas during the course of PDUFA V. For each disease area, the FDA will conduct a public meeting to discuss the disease and its impact on patients’ daily lives, the types of treatment benefit that matter most to patients, and patients’ perspectives on the adequacy of available therapies. The Patient-Focused Drug Development meeting schedule indicates that the narcolepsy meeting will be held in September 2013.