FDA Defends Lab Test Oversight Before Critical Lawmakers

By Jeff Overley (September 9, 2014, 1:21 PM EDT) -- A high-ranking U.S. Food and Drug Administration official pushed back hard Tuesday on Capitol Hill against criticism of agency plans to regulate sophisticated lab tests, saying there's clear legal authority for oversight and that ensuring accurate diagnoses is crucial to personalized medicine's future.

Jeffrey E. Shuren, director of the FDA's Center for Devices and Radiological Health, mounted the defense after encountering pointed questioning at a House Energy and Commerce Committee hearing about looming requirements for so-called laboratory developed tests to sometimes seek agency approval.

A recurring complaint from Republican lawmakers — echoed later in the hearing by representatives of clinical laboratories...

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