Targeting Biomarkers and the FDA’s Biomarker Qualification Framework

Key Points

• The viewpoint advocates for the inclusion of targeting biomarkers in the FDA's framework for biomarker qualification.
• Analysis of the current FDA biomarker qualification framework.
• Discussion of benefits and implications of targeting biomarkers.
• Proposes a new category for more specific biomarker assessment.
• Highlights potential improvements in drug development and regulatory approvals.

Abstract