Two Forces Push for More FDA Oversight of LDTs

CLINICAL AND GENETIC TESTING LABS MAY SUDDENLY FEEL THEMSELVES STUCK IN THE MIDDLE of a yin-yang situation when it comes to laboratory developed tests (LDTs). One force, the U.S. Food and Drug Administration (FDA), is pulling on laboratories by proposing more stringent requirements for LDTs. Another force, this one by means of Congress, is attempting …

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Two Forces Push for More FDA Oversight of LDTs

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