FDA, NIH and Industry Publish Framework for Biomarker Qualification

Officials from the FDA and the National Institutes of Health, in cooperation with public, private and industry stakeholders published a framework for defining the levels of evidence needed to support the regulatory qualification of biomarkers for drug development.

The framework suggests developers focus on five steps: describing a statement of need, defining a specific context of use, performing benefit and risk analyses, and describing the available evidence.

The Foundation for the NIH, along with PhRMA, the Critical Path Institute, and pharmaceutical companies including Genentech, Merck, Pfizer and Takeda, anticipate that these criteria will help the FDA develop industry guidance in biomarker qualification. The framework does not consider biomarkers for in vitro diagnostic tests regulated by CBER and CDRH.