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Former FDA Chief Counsel Expects Lawsuits Over Agency's LDT Proposal

05 Oct 2023

Clinical labs seem poised to file lawsuits arguing that the US Food and Drug Administration does not have the right to regulate lab-developed tests. And those lawsuits have some chance of success, former FDA chief counsel Dan Troy told Medtech Insight.

Expect a legal battle before the US Food and Drug Administration’s proposed rule on lab-developed tests can be put into effect, a former FDA chief counsel told Medtech Insight.

Dan Troy, who is now a managing director specializing in the healthcare sector at Berkeley Research Group, was the FDA’s chief counsel from 2001-2004