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Clinical Laboratories Laboratory Developed Tests Medical Research

Gardner Law

LDT Rule Vacated: FDA Backs Down, but Uncertainty Remains

Gardner Law on

In December 2024, we published an alert highlighting the FDA’s final rule on Laboratory Developed Tests (LDTs) and the compliance countdown to May 2025. The rule, issued in May 2024, sought to phase out the agency’s...more

Mintz - Health Care Viewpoints

FDA’s Evolving Response to the COVID-19 (Coronavirus) Outbreak

Within the U.S. Department of Health and Human Services (HHS), many agencies have responsibility for responding to public health emergencies. The Centers for Disease Control and Prevention (CDC), as its name implies, is at...more

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