Clinical laboratories still face uncertainty and the difficult decision of whether to start the work needed to comply with ...

Section 5A RTA 1988 - Driving or being in charge with concentration of specified controlled drug above specified limit The offence at section 5A RTA 1988 is driving, attempting to drive or being in ...

The pathologists group wants the regulation terminated in light of an executive order from President Trump that calls for ...

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 ...

An example of these ongoing threats recently materialised in the FDA’s final rule on laboratory-developed tests (LDTs). This recent change, which will be phased out in four years, categorises ...

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 ...

The FDA’s final rule for lab-developed tests (LDTs) is in litigation, and a district court decision may be shortly in the works.

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 ...

President Donald Trump issued the executive order “Ensuring Lawful Governance and Implementing the President’s ‘Department ...

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.

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 ...