US FDA Should Explain How It Uses Patient Experience Data In Drug Approvals – Report
Review documents do not always reflect whether PED was considered as part of an application, and stakeholders cannot easily determine how such data are used in the agency’s regulatory decision-making, an independent consultant review found.
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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.
Final FDA guidance also suggests sponsors recruit representative populations and limit exclusions.
US FDA’s New ‘Integrated’ Review Process Starts To Win Over Skeptics, But Industry Still Wants More Details
In an interview with the Pink Sheet, implementation director Rhonda Hearns-Stewart says FDA has modified the template for its 'integrated assessment' of marketing applications in response to feedback from reviewers and sponsors.