JD Supra15d
A Regulatory Haze of Uncertainty Continues as the Clock Ticks Toward Phase One of FDA’s LDT Final Rule
Clinical laboratories still face uncertainty and the difficult decision of whether to start the work needed to comply with the with Phase ...
The National Law Review15d
A Regulatory Haze of Uncertainty Continues as the Clock Ticks Toward Phase One of FDA’s 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 ...
MedTech Dive15d
CAP urges HHS to revoke lab developed test rule, citing Trump order
The pathologists group wants the regulation terminated in light of an executive order from President Trump that calls for ...
Yahoo Finance15d
CAP urges HHS to revoke lab developed test rule, citing Trump order
The Food and Drug Administration released a final rule on LDTs in April. Despite industry opposition, the agency has changed the regulations to classify diagnostics made by laboratories as medical ...
BioWorld16d
Loper Bright no free pass where FDA’s LDT rule is concerned
The FDA’s final rule for lab-developed tests (LDTs) is in litigation, and a district court decision may be shortly in the works.
BioWorld16d
FDA’s LDT rule, CDS guidance combine to complicate regulatory life
The routine use of software to interpret the results of lab-developed tests (LDTs) leaves clinical labs in a complicated spot in 2025 thanks in no small part to an ongoing lawsuit over the U.S. FDA’s ...
American Bar Association16d
FDA’s Final Rule on Regulation of Lab-Developed Tests: A Changing Landscape
On May 6, 2024, the FDA published its much-anticipated Final Rule on Lab-Developed Tests (LDTs). The Final Rule ended FDA’s longstanding policy of not actively regulating LDTs pursuant to its ...
WWNO16d
Did a new Alzheimer's drug keep this patient's brain healthier for longer?
In 2020, Sue Bell became one of the first Alzheimer's patients in the U.S. to receive the drug now marketed as Leqembi. Four years later, she and her husband, Ken, halted the treatment.
CNN17d
FDA delays when a final rule on what foods can be labeled as ‘healthy’ goes into effect
The US Food and Drug Administration’s new standards for foods before they can be labeled as “healthy” on their packaging will go into effect about two months later than planned, according to ...