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

Litigation against the FDA's Final Rule on lab-developed tests (LDTs) is causing uncertainty to rise as the US regulator gears up for a legal clash with the lab industry. Since the FDA revealed ...

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

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

Marty Makary, President Trump’s pick to lead the Food and Drug Administration (FDA), will testify before the Senate Health, ...

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 ...

Dr. Marty Makary is largely sidestepping Senate questions about his plans to lead the Food and Drug Administration.

But LDTs have grown in use over the years, as have concerns over their lack of regulatory oversight. Common LDTs today include tests for COVID-19, blood level tests and tests for drug abuse. While ...

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 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 ...