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With LDT Rule Vacated, Labs Await FDA Response

Also in the April 21, 2025 issue, pharmacies are cutting back on their primary care offerings

In a major win for clinical laboratories, a federal judge vacated the FDA’s final rule on LDTs, writing in his decision that the agency overstepped its authority. For now, labs can develop and modify LDTs without FDA oversight, but future action in some form is likely. In part one of our report about the decision, […]

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