Patient-Focused Drug Development Events May Be Giving Way To Small, Private Meetings With FDA
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.
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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.
US FDA’s Theresa Mullin envisions having a national catalog of standard core clinical outcomes assessment measures that could apply to every disease area.
Patient-focused drug development final guidance is little changed from 2019 draft but urges that quantitative data collection methods for issues important to patients need to easily usable by individuals with different abilities and cultural backgrounds.