JD Supra6h
District Court Vacates FDA LDT Rule; What’s Next for Regulation of Lab Testing?
Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas issued an opinion and judgment in ...
MedTech Dive3d
Texas judge overturns FDA’s lab developed test regulation, siding with industry groups
The judge vacated the FDA’s final rule, which was strongly opposed by the laboratory industry, and remanded the matter to HHS ...
American Hospital Association3d
Court strikes down FDA rule on regulating lab-developed tests
The U.S. District Court for the Eastern District of Texas March 31 ruled that the Food and Drug Administration does not have ...
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 ...
JD Supra1d
Texas Court Vacates FDA’s Laboratory Developed Test (LDT) Final Rule
A Texas judge for the U.S. District Court for the Eastern District of Texas issued a ruling on March 31, 2025, to vacate and set aside, in ...
Federal Court 'Vacates in Its Entirety' the FDA's Costly and Onerous Lab Test Rule
A federal district court has struck a blow for medical innovation and patient empowerment by overruling the Food and Drug ...
GlobalData on MSN3d
FDA’s LDT rule struck down in Texas court
A Texas judge has ruled against the US Food and Drug Administration (FDA) in a court case that challenged the agency’s plans ...
360Dx3d
Future of LDT Oversight Unclear Following Court's Rejection of FDA Rule
The ruling makes clear that the FDA lacks the legal authority to regulate LDTs, and observers suggest it could also call into question its authority in other areas.
360Dx4d
Federal Court Vacates FDA Rule on Laboratory-Developed Tests
The ruling prevents the FDA rule on LDTs, which is opposed by much of the clinical lab industry and many segments of the broader healthcare industry, from going into effect.
The National Law Review3d
Texas Court Vacates FDA’s Laboratory Developed Test (LDT) Final Rule
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 ...
Yahoo Finance3d
FDA’s LDT rule struck down in Texas court
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 ...