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# Guidance on Histopathology to Support Biomarker Qualification
- URL: https://www.fdaweb.com/guidance-on-histopathology-to-support-biomarker-qualification/
- Published: 2016-05-13T12:00:00.000Z
- Updated: 2026-09-14T21:02:47.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5135663

FDA has posted a [guidance](https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-11438.pdf?ref=fdaweb.com) on “Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification.” The FDA Critical Path Initiative identified the discovery, characterization, qualification, and use of biomarkers as important for improving medical product development efficiency and success rates, the document notes. “The type of study reports to be submitted in support of a biomarker qualification will depend upon the proposed context of use and the ultimate goal of the submission,” the agency says. “The proposed context of use dictates the depth, extent, and rigor of the supporting data for the biomarker. If a biomarker becomes qualified, analytically valid measurements of it can be relied upon to have a specific and interpretable meaning (e.g., physiologic, toxicologic, pharmacologic, or clinical) in drug development and regulatory decision-making. Industry can then employ the biomarker for the qualified context of use during premarketing drug development, and FDA reviewers can be confident about its qualified context of use without the need to reconfirm its applicability or utility. Accordingly, data supporting qualification of a nonclinical biomarker should be reliable, repeatable, and of assured integrity.”