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Clinical Labs Lawyer Up In Battle Over LDTs

ACLA has recruited Laurence Tribe and Paul Clement, two prominent constitutional legal guns with Supreme Court expertise, to fight FDA over its proposed lab-developed test guidance. The announcement is perhaps the lab industry's most high profile move yet to oppose FDA's plan to regulate lab-developed test services under the device statute with a risk-based phase-in plan.

The American Clinical Laboratory Association has hired former Solicitor General Paul Clement and Harvard Law Professor Laurence Tribe – prominent attorneys with Supreme Court experience – to help it “persuade” FDA to withdraw its proposed laboratory-developed test guidance

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