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

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...

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

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

Yesterday, the Food & Drug Administration (“FDA” or “the Agency”) issued a highly anticipated – and highly controversial – final rule, which rolls out a four-year, five-stage plan that...