As the US Food and Drug Administration’s patient-focused drug development initiative hits the 10-year mark, stakeholders are eyeing ways the program has evolved and additional changes they would like to see.
US Patient-Focused Drug Development Meetings Changing With The Times
Meetings are now primarily hosted by external patient advocacy groups, with accelerated approval and surrogate endpoints making their way into discussions. Stakeholders want more transparency on how FDA uses PFDD reports, and one agency staffer suggests adding other types of expertise to the meetings.
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