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FDA Finalizes Rule and Sets Course to Phase In Oversight of Laboratory Developed Tests | Goodwin

On May 6, 2024, following more than a decade of discourse with interested stakeholders on potential approaches to regulation of laboratory developed tests (LDTs), the U.S. Food and Drug...
Certain In Vitro Diagnostics Pilot Program Department Of Defense Do Drug Administration Clinical Laboratory Improvement Amendments Public Health Surveillance Veterans Health Administration

FDA Makes Good on Its Promise to Regulate Laboratory-Developed Tests | Sheppard Mullin Richter & Hampton LLP

Yesterday, the Food & Drug Administration (โ€œFDAโ€ or โ€œthe Agencyโ€) issued a highly anticipated โ€“ and highly controversial โ€“ final rule, which rolls out a four-year, five-stage plan that...
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