News

MedTech Dive3d
FDA declines to appeal court order that stopped LDT final rule
The Trump Administration has effectively ended the Biden Administration's attempt to regulate lab-developed tests,” TD Cowen ...
American Hospital Association2d
FDA doesn’t appeal court ruling invalidating lab-developed tests rule, effectively eliminating it
A 60-day appeal window has passed for the Food and Drug Administration to appeal a federal court ruling that invalidated its ...
Becker's Hospital Review2d
FDA will not appeal court decision striking down lab-developed test rule: 5 notes
The FDA has opted to not appeal a federal court decision that struck down the agency’s rule to regulate laboratory-developed tests as medical devices. The 60-day window for appeal has passed, ...
FDA Skips Move to Revive Suit Over Agency’s Lab Test Authority
The Trump administration declined to appeal a court decision that ruled the FDA lacked the legal authority to regulate ...
Healthcare Dive2mon
Texas judge overturns FDA’s lab developed test regulation, siding with industry groups
The American Clinical Laboratory Association ... that the best way to ensure the continued development of accurate LDT procedures and the correct interpretation and use of molecular test results ...
JD Supra2mon
Texas Court Vacates FDA’s Laboratory Developed Test (LDT) Final Rule
The ruling prevents the LDT Final Rule – a rule heavily criticized by many clinical laboratory industry stakeholders – from going into effect. Prior to the LDT Final Rule, FDA exercised ...
BioSpace4d
Post-Chevron Legal Battles: Three Key Cases to Watch
The overturning of the FDA’s lab-developed tests rule is just the tip of the iceberg. With the loss of Chevron deference, ...
Healthcare Dive7mon
5 steps to navigate the FDA’s new lab developed test rule
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 ...
Hosted on MSN2mon
FDA’s LDT rule struck down in Texas court
Filed by the American Clinical Laboratory Association (ACLA), member ... industry at a ‘practical standstill’. "FDA’s LDT rule struck down in Texas court" was originally created and ...
Taiwan News16d
U.S. IVD and LDT Market for Autoimmune Diseases, Diagnostic Innovation and Regulatory Shifts Driving Growth Through 2033
The U.S. In Vitro Diagnostics (IVD) and Laboratory-Developed Tests (LDT) market for autoimmune diseases is set to witness transformative growth over the next decade. Valued at USD 2.51 billion in 2023 ...
Yahoo Finance2mon
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 ...
The National Law Review2mon
Texas Court Vacates FDA’s Laboratory Developed Test (LDT) Final Rule
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