Targeting Biomarkers and the FDA’s Biomarker Qualification Framework

This Viewpoint argues for adding a new category, targeting biomarkers, to the US Food and Drug Administration’s biomarker qualification framework.

Corresponding Author: Hamed Ekhtiari, MD, PhD, Department of Psychiatry, University of Texas Southwestern, 1440 Empire Central Dr, Dallas, TX 75247 (hamed.ekhtiari@utsouthwestern.edu).

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