How FDA Differs From CMS In Clinical Lab Test Oversight

Law360, New York (March 14, 2013, 12:36 PM EDT) -- The U.S. Food and Drug Administration has previously announced an interest in regulating diagnostic tests used in providing personalized medicine clinical care. Interested stakeholders such as the American Clinical Laboratory Association, the College of American Pathologists and the Association for Molecular Pathology, have weighed in on whether the FDA can and should expand its jurisdiction to laboratory-developed tests (LDTs) performed by clinical laboratories.

Toward the end of understanding the issues and concerns of stakeholders and the public, the Personalized Medicine Coalition (PMC) recently issued a white...
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