> ## Content Index
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# Biomarker Qualification Case Studies
- URL: https://www.fdaweb.com/biomarker-qualification-case-studies/
- Published: 2017-06-15T12:00:00.000Z
- Updated: 2026-09-14T22:29:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138940

FDA has published fictional [case studies](https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/BiomarkerQualificationProgram/ucm562669.htm?ref=fdaweb.com) as part of an educational series on qualifying biomarkers for use in drug development. The agency says the studies “are intended to help patients, patient advocacy groups, health professionals, small businesses, and pharmaceutical and clinical innovators learn more about the role of biomarkers and biomarker qualification in drug development. They provide ‘real-world’ examples of how biomarkers can improve the drug development process and how FDA works with researchers, pharmaceutical companies, and patient advocates to qualify innovative biomarkers.”