• ePolicy News January 2015

    January 12, 2015
    FDA LDT Proposal Under the Microscope
    The controversy over the regulation of laboratory developed tests (LDTs) heated up this month in a public forum organized by the Food and Drug Administration (FDA) to discuss its proposal for a risk-based approach to regulate these assays. The Agency’s issuance last fall of a proposed framework for the regulation of LDTs signaled the end of the FDA's long-standing policy of "enforcement discretion." Read more