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Medical Device Clinical Trials

FDA On Personalized Medicine: Don’t Skimp On Diagnostic Quality Development

This article was originally published in The Gray Sheet

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Executive Summary

A CDRH representative tells a conference on drug/diagnostic co-development that it doesn’t matter how well designed a study for a therapeutic agent is if the accompanying biomarker-targeted test is not reliable and uniformly implemented.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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