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 and ...
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) regulation of ...
Laboratories are just beginning to assess the magnitude of operational changes needed to comply with a new federal rule expanding regulatory oversight of lab developed tests (LDTs). In a major shift, ...
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Judge foils FDA plan to regulate lab-developed tests
Folks with cancer that has gene variants or rare diseases often need laboratory-developed tests for information that could guide their treatment when commercial tests don’t exist or aren’t precise ...
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 and ...
A Texas federal court on Monday struck down the Food and Drug Administration’s new rule regulating laboratory developed tests as medical devices in a victory for the clinical lab industry. Judge Sean ...
The winding road of laboratory-developed test (LDT) regulations is likely to see another twist as the recent election of Donald Trump to a second US presidential term puts FDA’s final rule on the line ...
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) regulation of ...
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