2023-09265: Methodological Challenges Related to Patient Experience Data; Request for Information and Comments
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The Food and Drug Administration (FDA or Agency) is establishing a public docket to collect comments on methodological challenges related to patient experience data in the context of the benefit-risk assessment and product labeling, and other areas of greatest interest or concern to public stakeholders. Public comments will help FDA plan two public workshops focused on methodological challenges and identify priorities for future work.
The agency’s own summary, as published.
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