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Ther Deliv. 2010 Nov;1(5):631-41.

Biomarkers to improve the benefit/risk balance for approved therapeutics: a US FDA perspective on personalized medicine.

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Division of Biology, Office of Science & Engineering Laboratories, CDRH, US Food & Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.


This article highlights a current US FDA perspective concerning the use of biomarker-based diagnostics for personalized medicine. Specifically, current biomarkers that have application for improving the benefit/risk profile of already approved drugs are discussed. The success of biomarkers for use in personalized medicine depends on many factors, including proper evaluation of the usefulness of the biomarker for assessing the event of interest, and the safety and effectiveness of the diagnostic device used to measure the biomarker, which includes appropriate analytical and clinical validation. These points along with the many regulatory concerns regarding co-labeling of drugs and devices and future aspects, such as co-development, will be discussed in this regulatory science focus.

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