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.
Former FDA Chief Counsel Expects Lawsuits Over Agency's LDT Proposal
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.
![Legal case in court](https://insights.citeline.com/resizer/v2/NE6WSO356VNCRLQYVYOUJ7P4P4.jpg?smart=true&auth=fd66b85515ba9c93763aa33a303eae54d5ff5c8871e0413c98474f781549722a&width=700&height=394)
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A flurry of firings as part of the Trump administration’s pledge to shrink the federal government hit the FDA over the weekend. While the exact number of staff let go is unclear, the agency’s device center took the brunt of it.
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A federal judge granted Doctors for America’s motion for a temporary restraining order directing the FDA and CDC to restore information removed from the agencies’ websites to comply with a presidential executive order targeting “gender ideology extremism.”