The recent landmark U.S. Supreme Court decision to overturn the Chevron doctrine could open the door to more challenges of Food and Drug Administration regulations, including the agency’s ...

The Food and Drug Administration aims next year to toughen up regulations on the lab-developed testing industry, according to an article in The Wall Street Journal. Here are three things to know about ...

The market for lab-developed tests, now worth $4.5 billion globally, is expected to see 7 percent compound annual growth through 2028, according to a new Research and Markets report. The report ...

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 shift, ...

A federal judge in Texas ruled that the FDA overstepped its authority when it issued its Final Rule: Medical Devices; Laboratory Developed Tests in May of last year, which said laboratory-developed ...

The Biden administration's contentious plan to increase federal regulation of diagnostic medical tests could be swiftly ...

A group representing clinical labs across the country sued the Food and Drug Administration on Wednesday over the agency’s plan to actively regulate lab-developed tests. The suit, filed in a Texas ...

The 2024 election results will have vast consequences for health policy, but one of the less visible effects will be to once again disrupt how the federal government regulates diagnostic tests.

The U.S. trade group representing laboratory companies and test manufacturers is suing to block the FDA from increasing its oversight of lab-developed tests, saying the agency overstepped its ...

Stable isotope-labeled internal standards are widely used in laboratory-developed clinical mass spectrometry tests. An equal amount of these internal standards is added to all samples in a batch, ...