Medical Device Network on MSN14h
FDA’s LDT rule struck down in Texas court
Published in 2024, the FDA’s ‘Final Rule’ outlined plans to subject lab-developed tests to the same requirements as medical ...
STAT1d
Texas judge strikes down FDA’s plan to regulate lab-developed tests
The FDA has long believed it has the power to regulate lab-developed tests, but it only put out the rules under former ...
MedTech Dive10h
Texas judge overturns FDA’s lab developed test regulation, siding with industry groups
The judge vacated the FDA’s final rule, which was strongly opposed by the laboratory industry, and remanded the matter to HHS ...
American Hospital Association5h
Court strikes down FDA rule on regulating lab-developed tests
The U.S. District Court for the Eastern District of Texas March 31 ruled that the Food and Drug Administration does not have ...
Fierce Biotech10h
Federal judge blocks FDA’s regulation of lab-developed tests
A federal judge in Texas has blocked the FDA’s plans to bring laboratory-developed tests under the same regulations it uses ...
AFRO American Newspapers2h
Breaking News: RFK Jr. oversees mass and sudden firings at FDA
Mass firings and forced resignations sweep through the U.S. Food and Drug Administration under a new directive from the ...
Recent Texas recalls to know about: From bleach in eggs to wood in frozen meals
The U.S. Department of Agriculture's Food Safety and Inspection Service announced last week about 212,000 pounds of liquid ...
Becker's Hospital Review10h
Court strikes down FDA rule to regulate hospital lab tests
A federal judge in Texas has ruled that the FDA does not have the authority to regulate laboratory developed tests as medical ...
Dallas County cancels 50 community vaccination events as DOGE cuts CDC, FDA jobs
The Trump administration's decision to drastically reduce the federal workforce is impacting North Texas as dozens of ...
National Law Review1d
In Landmark Ruling, Eastern District of Texas Strikes Down FDA’s Final Rule Regulating Laboratory Developed Tests
In the never-ending saga over the battle to regulate laboratory-developed tests (LDTs), the Eastern District of Texas took ...
FDA Lacks Authority to Regulate Laboratory Tests, Judge Rules
A federal judge ruled Monday that the FDA doesn’t have the legal authority to regulate lab-developed tests, dealing a blow to ...
Endpoints News16h
Fed­er­al judge nix­es FDA's lab-de­vel­oped test rule, says it ex­ceed­ed agen­cy's au­thor­i­ty
The FDA overstepped its authority when it issued a rule last May to bring laboratory-developed tests under the agency’s ...