The US Food and Drug Administration perspective on cancer biomarker development
- PMID: 16794639
- DOI: 10.1038/nrc1911
The US Food and Drug Administration perspective on cancer biomarker development
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?
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