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  1. Center for Drug Evaluation and Research (CDER)

FDA Biomarkers Working Group


The mission of the FDA Biomarker Working Group (BWG) is to:

  •  promote communication across FDA on scientific issues related to biomarker development and regulatory acceptance;
  • identify process and policy enhancements that may help address challenges; and
  • coordinate activities and leverage resources that have an impact on multiple Centers.


  • Identify areas of common interest or cross-Center needs related to biomarker activities and create proposals or work plans to address those areas or needs
  • Share information about biomarker activities that may be of interest to a broader internal or external audience
  • Provide recommendations for IT, research, and other tools that would promote FDA’s biomarker review and development goals
  • Identify and develop staff educational opportunities that foster better understanding of biomarker science and improve the regulatory process
  • Sharing of information on guidance documents relevant to biomarkers

All Centers are represented in the working group. Members of the working group are vetted and approved by the Centers’ senior management.

The working group report to the FDA Senior Science Council and the Chief Scientist.   

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