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

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.

Diagnostic test quality may not be something that many drug makers have a lot of experience dealing with, but shortfalls in a diagnostic development program can undercut efforts to streamline clinical trials for personalized medicines.

The need for a high-quality diagnostic test development program was a key message delivered by a representative from FDA’s device center at a Sept

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