Alexis Boaz

Alexis Boaz

Epstein Becker & Green

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A Final Rule Bites the Dust: Federal Court Rules FDA Lacks Authority to Regulate LDTs

The order is in, and the LDT Final Rule is out. In May 2024, the U.S. Food & Drug Administration (“FDA” or the “Agency”) published its Final Rule establishing its regulatory framework over laboratory developed tests...more

4/1/2025  /  Final Rules , Food and Drug Administration (FDA) , Judicial Authority , Laboratory Developed Tests , Life Sciences , Medical Devices , Regulatory Authority , Statutory Interpretation
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