Exclusive Interview

FDA Personalized Medicine Chief: Labs Will Be ‘Generally Pleased’ With Final LDT Guide

July 31, 2015 at 12:43 PM
FDA personalized medicine chief Elizabeth Mansfield told Inside Health Policy she expects laboratories will be “generally pleased” when the final version of the agency’s laboratory-test guidance emerges, adding stakeholders can expect an updated document that will include a “reasonable number of changes” and be more aligned with what industry would like. In an exclusive interview with IHP , she addressed some of the key concerns stakeholders raised with the draft guidance, including its treatment of clinical validity of tests,...


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