The Trump Administration has effectively ended the Biden Administration's attempt to regulate lab-developed tests,” TD Cowen ...

The Trump administration declined to appeal a court decision that ruled the FDA lacked the legal authority to regulate ...

Last week, readers were most interested in a story about the FDA's decision not to appeal a court decision vacating the agency's LDT rule.

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The overturning of the FDA’s lab-developed tests rule is just the tip of the iceberg. With the loss of Chevron deference, ...

Litigation against the FDA's Final Rule on lab-developed tests (LDTs) is causing uncertainty to rise as the US regulator gears up for a legal clash with the lab industry. Since the FDA revealed ...

A Texas judge has ruled against the US Food and Drug Administration (FDA) in a court case that challenged the agency’s plans to regulate laboratory-developed tests (LDTs) – defined as in vitro ...

Lawmakers have told the Food and Drug Administration to suspend efforts to implement its final rule on laboratory developed tests (LDTs). The House Appropriations Committee made the request ...

He concluded, “We believe with LISA resources and support, our members will be able to successfully navigate all phases of the Final FDA LDT rule.” Key Players in LISA LISA brings together ...

DENTON, Texas, April 1, 2025 /PRNewswire/ -- HealthTrackRx, a leader in molecular diagnostics and named plaintiff in the lawsuit challenging the U.S. Food and Drug Administration's (FDA ...

These UTI projects mark a new era where accredited clinical labs cooperate with industry to develop cutting-edge assays that comply with FDA's Final LDT Rule. Under LISA, the UTI projects will ...