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Regulatory landscapes for biomarkers and diagnostic tests: Qualification, approval, and role in clinical practice

William B Mattes1, Federico Goodsaid2

  • 11 National Center for Toxicological Research, US Food and Drug Administration, Jefferson, AR 72079, USA.

Experimental Biology and Medicine (Maywood, N.J.)
|November 8, 2017
PubMed

Keywords:
BiomarkersFood and Drug Administrationdiagnosticdrugsqualificationvalidation

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