FDA Issues Draft Guidelines on Qualifying Biomarkers to Speed Rx Development

The draft document, titled "Qualification Process for Drug Development Tools," lays out the process by which industry can receive FDA's go-ahead for biomarkers, including pharmacogenomic markers, for use in a specific context. After getting these biomarkers "qualified" by the FDA, industry can use these markers in a similar context in multiple drug trials, drug classes, or clinical disorders, without having to repeatedly seek the agency's approval.

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