The Final Rule provided for different levels of enforcement ... this chapter of the decades-long LDT saga may be winding down, FDA has not yet been written out of the story. Even though the ...

On March 31, 2025, the U.S. District Court for the Eastern District of Texas ruled that the Food and Drug Administration (FDA) lacks the ...

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Upon the Final Rule’s release last year ... the diagnostics industry at a ‘practical standstill’. "FDA’s LDT rule struck down in Texas court" was originally created and published by ...

“The LDT concept is sort of like a vampire ... manufacture and use their own diagnostic tests, the FDA’s final rule would have regulated LDTs as medical devices. Over four years, it would ...

"The LDT final rule would have stifled medical innovation and dramatically increased regulatory burden and costs for both hospitals and the federal government." Karcher said that the now-dismissed ...

The U.S. FDA famously lost a lawsuit over its final rule for regulation of lab-developed tests (LDTs), but Jeff Shapiro of King & Spalding told BioWorld that the implications of this decision go ...

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation ...

“The LDT concept is sort of like a vampire ... manufacture and use their own diagnostic tests, the FDA’s final rule would have regulated LDTs as medical devices. Over four years, it would have phased ...