Biomarker qual

WHO: CDER

WHAT:  To facilitate drug development process by  supporting  regulatory qualification of  biomarker for a particular context of use

WHY: 

  • Provide framework for development and regulatory acceptance
  • Facilitate integration into regulatory review
  • Encourage identification of new and emerging biomarkers
  • Support outreach to stakeholders

HOW: Submit biomarker for qualification

LINK

Published by Drug & Device Advisory Group


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