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# Biomarker Evidentiary Criteria Framework Released
- URL: https://www.fdaweb.com/biomarker-evidentiary-criteria-framework-released/
- Published: 2016-12-06T12:00:00.000Z
- Updated: 2026-09-14T21:52:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137505

The Foundation for the National Institutes of Health 12/6 released its *Framework for Defining Evidentiary Criteria for Biomarker Qualification*, developed in collaboration with FDA, NIH, the Critical Path Institute, PhRMA and numerous drug companies, including Genentech, Merck, Pfizer and Takeda. The [44-page document](http://fnih.org/sites/default/files/final/pdf/Evidentiary%20Criteria%20Framework%20Final%20Version%20Oct%2020%202016.pdf?ref=fdaweb.com) incorporates input from nearly 200 scientific leaders in the field. “It’s hard to overestimate the potential impact of the work that is being done here,” CDRH director **Janet Woodcock**, said about this effort during her keynote address at an April 2016 workshop on this topic.

According to a foundation announcement, progress in the use of biomarkers in drug development has been hampered by the lack of clear, predictable and specific regulatory criteria for the evidence required to qualify new markers. The *Framework* document seeks to address these issues through a defined framework that suggests biomarker developers focus on five specific steps: describing a statement of need, defining a specific context of use, performing a benefit analysis, performing a risk analysis and concisely describing available evidence. It is hoped that the framework will promote collaborative discussions between biomarker developers and the FDA, improve upon the quality of biomarker qualification submissions to the FDA and inform future FDA efforts to develop relevant guidance for evidentiary criteria in biomarker qualification.