USA – Qualification of Biomarker — Galactomannan in studies of treatments of invasive

This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the Center for Drug Evaluation and Research, Biomarker Qualification Program…