FDA Watch: How Could the End of Chevron Impact the FDA and LDTs?
A lawsuit by a group of herring fishermen upended 40 years of legal precedent regarding how federal agencies interpret statutes
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Special Analysis: Addressing Key Concerns Around the FDA’s Final LDTs Rule
Experts answer key questions related to laboratory-developed test regulation during G2 Intelligence webinar.
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ACLA Sues FDA Over Regulation of Laboratory-Developed Tests—in Texas
The choice of venue was likely inspired by the longstanding anti-regulatory stance of the state's federal judges.
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New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
Getting Started with the FDA’s New LDT Rule
Experts explain what the phase-in process will look like—and how labs can get ahead of the game.
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