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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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United States - - Will FDA's LDT Final Rule Bring "Balance To The (IVD) Force"?

The U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286) that will, over the next four years, radically alter the landscape for laboratory developed tests (LDTs). ....

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Will FDA's LDT Final Rule Bring "Balance to the (IVD) Force"? | Venable LLP

The U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286) that will, over the next four years, radically alter the landscape for. ....

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FDA Finalizes LDT Regulation, With Significant Exceptions: Enforcement Of Requirements Will Phase In Over Four Years - Healthcare

FDA Finalizes LDT Regulation, With Significant Exceptions: Enforcement Of Requirements Will Phase In Over Four Years - Healthcare
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FDA's Final LDT Rule Is Here, and the Changes Show the Agency Is Serious and Actually Listening to Stakeholders | Mintz - Health Care Viewpoints

FDA's Final LDT Rule Is Here, and the Changes Show the Agency Is Serious and Actually Listening to Stakeholders | Mintz - Health Care Viewpoints
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