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Loper Bright Renews Interest in the VALID Act

Loper Bright Renews Interest in the VALID Act

by Christine P. Bump | Aug 30, 2024 | Essential, Lab Industry Advisor, Legislation-lca

The US Supreme Court decision that recently overturned the Chevron doctrine is influencing potential enactment of new legislation

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FDA Watch: How Could the End of Chevron Impact the FDA and LDTs?

FDA Watch: How Could the End of Chevron Impact the FDA and LDTs?

by Ron Shinkman | Jul 24, 2024 | Essential, FDA-lca, Lab Industry Advisor, LDTs-lir

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

Special Analysis: Addressing Key Concerns Around the FDA’s Final LDTs Rule

by Scott Wallask | Jul 4, 2024 | Elite, FDA-lca, Lab Industry Advisor

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

ACLA Sues FDA Over Regulation of Laboratory-Developed Tests—in Texas

by Ron Shinkman | Jun 28, 2024 | Essential, FDA-lca, Lab Industry Advisor

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

New FDA LDTs Guidance Offers Useful Summary, But Questions Remain

by Rachel Muenz | Jun 27, 2024 | News

Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details

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