Astellas’ commitment to improving patient lives was exemplified at the 20th Patient-Focused Drug Development initiative meeting hosted by the U.S. Food and Drug Administration (FDA) on September 29, 2016, which focused on organ transplantation.
Held over the course of three years, from 2013 to 2015, each of the 20 meetings centered on a different disease area and were required for the fifth authorization of the Prescription Drug User Fee Act (PDUFA V) as part of the regulatory agency’s new initiative to gather patient perspectives on their condition, its impact on daily life and treatment approaches.
The aim has been to develop a greater understanding of disease severity and to identify the state of the current treatment armamentarium, providing the FDA with the opportunity to hear directly from patients and caregivers about their experiences with specific conditions and their treatments.
Patients or patient representatives actively participated in the meeting, either in person or through a live webcast. Others in attendance included representatives from FDA, other federal agencies, industry, healthcare professionals and patient organizations. Continue reading
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