'Patient Experience Data' Section Added To US FDA Drug Reviews
Genentech's hemophilia A treatment Hemlibra is among first products to include new dedicated section on patient experience data in its review documents as FDA begins implementing 21st Century Cures Act provision.
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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.
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.
RTI Health Solutions researchers assessed US FDA review documents over past two years to gauge use of a tool meant to facilitate agency disclosures about what patient experience information it considered.