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US Patient-Focused Drug Development Meetings Changing With The Times

 
• By Sue Sutter

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.

Medical textbook
PFDD meetings provide information not found in textbooks, FDA's Larissa Lapteva says. • Source: Alamy

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.

Primary responsibility for organizing and leading PFDD meetings in specific disease areas has shifted from the FDA to patient advocacy groups, and participants are increasingly being asked about their willingness...

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