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 ...

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 ...

HHS is withdrawing a 2020 policy that limited the FDA’s review process of certain lab tests, including some COVID-19 tests, the agency said Nov. 15. The policy was originally put in place to help labs ...

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 ...

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 ...

When the deadline to appeal the court decision that blocked the Food and Drug Administration’s final rule regulating laboratory developed tests as medical devices slipped by in May without a word from ...

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.

Historically, developing a molecular test within a clinical laboratory has been perceived as a complicated and laborious process. In this webinar, we aim to dispel common misconceptions of laboratory ...

As the new Congress and a new administration start up, the fate of FDA-issued regulations on laboratory-developed tests (LDTs) is one of many issues that health advocates and lobbyists will be ...