The US Food and Drug Administration perspective on cancer biomarker development.
review · Level V
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Abstract
Despite the intense interest in biomarker development for cancer management, few biomarker assays for diagnostic uses have been submitted to the US Food and Drug Administration (FDA). What challenges must researchers overcome to bring cancer-detection technologies to the market and, therefore, into clinical use?
Medical subject headings
- Biomarkers, Tumor
- Neoplasms
- Reagent Kits, Diagnostic
- United States Food and Drug Administration