In a set of newly released presentations, officials from the US Food and Drug Administration (FDA) explain changes to the agency's biomarker qualification program and detail early opportunities for ...

Industry, FDA Discuss Benefits of Data Sharing in Biomarker Development Data sharing is critical to the validation of new biomarkers used in drug development, experts at the seventh annual Predictive ...

The world is currently undergoing a significant transformation in biomarker science. Biomarker signatures are no longer academic luxury or exploratory afterthoughts; they have matured into strategic ...