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 ...

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 ...

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 ...

Kadakia is a medical student at Harvard Medical School. Ross and Ramachandran are physicians and professors at the Yale School of Medicine. They submitted an amicus brief in support of the FDA in ACLA ...

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 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 ...

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SALT LAKE CITY — Folks with cancer that has gene variants or rare diseases often need laboratory-developed tests for information that could guide their treatment when commercial tests don't exist or ...

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 ...