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 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 ...

Amid the upheaval, Grail continued to run studies to assess the ability of its Galleri blood test to detect a range of ...

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 ...

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 and ...

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 ...

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, ...

After nearly a year’s worth of trepidation about how laboratory-developed tests (LDTs) could be regulated, there appears to be no path for FDA to assume its oversight. The vacating of the final rule ...

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 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.