The FDA Biomarker Qualification Program

The FDA Biomarker Qualification Program is a process that allows researchers and companies to demonstrate that a specific biomarker—like a molecule in the blood or a genetic marker—can reliably indicate the presence of a disease or the effectiveness of a treatment. By qualifying a biomarker, the FDA establishes its scientific validity for use in drug development, which can streamline the process of bringing new therapies to market. This program helps ensure that treatments are safe and effective, benefiting both patients and the medical community by providing trusted tools for assessing health outcomes.