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FDA Watch: Discussion Paper Signals New Approach (Not Retreat) to LDT Regulation

by | Jan 23, 2017

After nearly two years of inactivity, things are suddenly heating up on FDA regulation of laboratory developed tests (LDTs). As promised, the agency took action on LDTs by the end of 2016—but not in the way everybody expected. Instead of finalizing the controversial rule it proposed in October 2014, the agency announced that it was […]

After nearly two years of inactivity, things are suddenly heating up on FDA regulation of laboratory developed tests (LDTs). As promised, the agency took action on LDTs by the end of 2016—but not in the way everybody expected. Instead of finalizing the controversial rule it proposed in October 2014, the agency announced that it was […]

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