Biomarker qualification pilot process at the US Food and Drug Administration

AAPS J. 2007 Mar 23;9(1):E105-8. doi: 10.1208/aapsj0901010.


New biomarkers of safety and efficacy are becoming powerful tools in drug development. Their application can be accelerated if a consensus can be reached about their qualification for regulatory applications. This consensus requires a review structure within the US Food and Drug Administration (FDA) that can evaluate qualification data for these biomarkers and determine whether these biomarkers can be qualified. A pilot process and corresponding Biomarker Qualification Review Team have been developed to test how the FDA can work on biomarker qualification.

MeSH terms

  • Biomarkers / analysis*
  • Drug Approval* / legislation & jurisprudence
  • Drug Approval* / methods
  • Drug-Related Side Effects and Adverse Reactions
  • Pharmaceutical Preparations* / standards
  • Pilot Projects
  • United States
  • United States Food and Drug Administration


  • Biomarkers
  • Pharmaceutical Preparations