US FDA’s Patient Input Guidance Opens Door Wider To Social Media Data Collection
Following stakeholder criticism of an earlier discussion paper, draft guidance does not automatically foreclose use of social media data as the primary source of qualitative research; however, agency says entities submitting such data for regulatory review must ensure rigor in methodology and data integrity.
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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.
US FDA Targets Migraine, Schizophrenia And Opioid Sparing Drugs For Clinical Outcome Assessment Development
Grant solicitation, a different approach than agency has so far taken with biomarkers, signals growing importance of patient input in drug development.
Agency wants public comment on creating clinical outcome assessments that could be adaptable to multiple trials.