A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?
FDA Law Blog
NOVEMBER 1, 2023
Indeed, recent jurisdictional developments suggest that a wide of array of stakeholders could have standing to challenge the Agency’s attempt to restrict access to commonly used LDTs, including individual laboratories, hospitals, physicians and healthcare providers who routinely use these tests, and patients who depend on them.
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