After weeks of skepticism and even industry figures calling its solid-state battery claims a ...

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 ...

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 ...

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 ...

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 ...

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 ...

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.