FDA Ends Regularly Scheduled Patient-Focused Drug Development Meetings
After conducting 24 disease-focused meetings in five years, FDA moving to next phase of patient interaction under new user fee cycle.
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A recent externally-led PFDD meeting on kidney xenotransplantation, rather than a specific disease, allowed for more tailored patient comments on the procedure, which could impact development plans going forward.
Patient listening sessions, which are easier to schedule, have overtaken traditional patient-focused drug development meetings in terms of volume, although US FDA’s data may be incomplete.
The popular patient-focused drug development model for new drugs might not fit for generics, in part because the affected patient groups would be much larger.