Sarcopenia and FDA’s Patient-Focused Drug Development Initiative

The Food and Drug Administration (FDA) has announced an opportunity for public comment related to the FDA’s patient-focused drug development initiative. This initiative is being conducted to fulfill the FDA performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). This effort provides for a more systematic approach under PDUFA V for obtaining the patient perspective on disease severity and currently available treatments for a set of disease areas. Sarcopenia is among the 16 diseases on the FDA’s preliminary list of nominated diseases for consideration during fiscal years 2016-2017. Comments in support of a meeting on this disease can be submitted until December 5, 2014. For details on how to submit comments electronically, please visit www.regulations.gov. We encourage you to weigh in!