FDA's Biomarker Qualification Program

The FDA's Biomarker Qualification Program is a process that evaluates and officially recognizes specific biological indicators—called biomarkers—that can reliably assess how a disease is progressing or how well a treatment is working. Once qualified, these biomarkers can be used confidently in multiple drug development programs and clinical trials, helping shorten the time and reduce the cost of bringing new medicines to patients. This program ensures that biomarkers are scientifically valid and consistently useful, ultimately supporting more efficient and effective decision-making in medical research and regulatory review.