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Labs and Industry Stakeholders Respond to FDA LDT Rule

Explore the response to the FDA's Laboratory Developed Tests, LDTs, final rule, including industry concessions, legal challenges, and legislative reactions. ....

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ARUP Statement on FDA Final Rule to Regulate Laboratory-Developed Tests as Medical Devices

ARUP Statement on FDA Final Rule to Regulate Laboratory-Developed Tests as Medical Devices
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Non-binding Guidance: FDA's Proposed Rule On Laboratory Developed Tests (Podcast) - Healthcare

Hi, I'm Greg Levine, head of the life sciences regulatory and compliance practice group in Ropes & Gray's Washington, D.C. office. ....

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FDA LDT Regulation

FDA LDT Regulation
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FDA's Proposed Rule on LDT Regulation and the Debate over Agency Deference | Sheppard Mullin Richter & Hampton LLP

Earlier this month, the Food and Drug Administration (“FDA” or “the Agency”) issued a highly anticipated proposed rule outlining the regulatory framework and implementation plan for. ....

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