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 ...
DENTON, Texas, April 1, 2025 /PRNewswire/ — HealthTrackRx, a leader in molecular diagnostics and named plaintiff in the lawsuit challenging the U.S. Food and Drug Administration’s (FDA) regulation of ...
WEST HILLS, Calif.--(BUSINESS WIRE)--Thermo Fisher Scientific, the world leader in serving science, today announced the launch of the TacroType™ Pharmacogenetic Test, a new laboratory developed test ...
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 ...
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 ...
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 ...
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