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CDER Patient-Focused Drug Development
FDA Issues Report “Assessment of the Use of Patient Experience Data in Regulatory Decision-Making”
The U.S. Food and Drug Administration has posted the 2026 report, “Assessment of the Use of Patient Experience Data in Regulatory Decision-Making.” The report describes findings from focus group interviews with FDA review staff about how patient experience data are considered throughout drug development and regulatory review, including FDA staff perspectives on the use and evaluation of patient experience data. It also examines reviewer-generated documents and approved product labeling for a cohort of 800 NDA, BLA, and efficacy supplement submissions approved between February 5, 2021, and December 31, 2025, to assess how patient experience data were documented.
This is the second in a series of three independent assessments required under Section 3004 of the 21st Century Cures Act, with reports in 2021, 2026, and 2031.
To view the 2026 report, please click here.
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To contact FDA's CDER Patient-Focused Drug Development Program Staff, please email patientfocused@fda.hhs.gov.
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