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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 ...
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 ...
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, ...
JD Supra1y
FDA’s Final LDT Rule Is Here, and the Changes Show the Agency Is Serious and Actually Listening to Stakeholders
The Food and Drug Administration (FDA) published its final rule on laboratory developed tests (LDTs) in the Federal Register on May 6, marking a watershed moment in the agency’s arduous decade ...
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 ...
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, ...
Hosted on MSN1mon
The FDA’s Final Rule on LDTs: gone for good?
In May 2024, the US Food and Drug Administration (FDA) issued its ‘Final Rule’, asserting that laboratory-developed tests (LDTs) - otherwise known as in vitro diagnostics (IVDs) - were medical ...
BioWorld4d
FDA declines to appeal court loss in LDT litigation
The U.S. FDA declined to appeal the outcome of a lawsuit eviscerating the agency’s final rule for regulation of lab-developed tests despite a 60-day window to do so.
Yahoo Finance1y
As FDA’s LDT rule looms, experts warn patients may lose access to critical tests
The FDA’s final rule on LDT regulation, which could come as soon as April, has unleashed a fierce debate over how to protect the health and safety of patients by ensuring tests developed in a ...
Hosted on MSN2mon
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 ...
One Year Later: FDA Deference After 'Loper Bright'
Attorneys discuss ‘Loper Bright Enterprises v. Raimondo’ and its impact to medical patent cases. Many anticipated that Loper Bright would lead to an increase in challenges to FDA’s authority and ...
Yahoo Finance3d
FDA declines to appeal court order that stopped LDT final rule
“This decision should finally conclude the FDA’s unwarranted and overreaching attempts to assert regulatory authority over LDTs,” AMP President Jane Gibson said in an emailed statemen ...