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# Guide on Clinical Outcome Assessments
- URL: https://www.fdaweb.com/guide-on-clinical-outcome-assessments/
- Published: 2023-04-06T12:00:00.000Z
- Updated: 2026-09-14T18:24:12.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5154149

*Federal Register* notice: FDA is making available a draft guidance entitled “Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making.” The document is the last of four in a series of methodological patient-focused guidances that describe how stakeholders (patients, researchers, medical product developers, and others) can collect and submit patient experience data and other relevant information from patients and caregivers to be used for medical product development and regulatory decision-making. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-04-06/pdf/2023-07243.pdf?ref=fdaweb.com).