Patient Experience Data May Require Separate Label, Genentech Suggests
US labeling for Genentech's Rituxan Hycela appears to have broken new ground with a 'Patient Experience' section describing summary data from a patient preference study; however, the company's global head of outcomes research says large volumes of patient-centric data would be difficult to reflect within the current labeling framework.
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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.
Patient-Focused Drug Development: US FDA’s Guidance Development Effort Passes The Mid-Point
Agency has issued two of four methodological draft guidances required under 21st Century Cures Act and convened workshops on the two documents still to come; industry, patient groups applaud FDA’s initiative but point to gaps in the guidance series, particularly around interactions with the agency on patient experience data and approaches to collecting patient preference information.
Keeping Track Of Oncology: US FDA Approves Herceptin Hylecta, Reviews Darolutamide And Pexidartinib
Oncology news and highlights from our US FDA Performance Tracker.