STAT13h
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 ...
National Law Review12h
Texas Court Vacates FDA’s Laboratory Developed Test (LDT) Final Rule
A Texas judge for the U.S. District Court for the Eastern District of Texas issued a ruling on March 31, 2025, to vacate and ...
Medical Device Network on MSN1d
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 ...
Judge foils FDA plan to regulate lab-developed tests
Folks with cancer that has gene variants or rare diseases often need laboratory-developed tests for information that could ...
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 ...
Fierce Biotech1d
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 ...
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 ...
American Hospital Association1d
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 ...
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 ...
U.S. Supreme Court backs up FDA rejection of marketing flavored vapes to youth
The U.S. Supreme Court on Wednesday upheld an FDA decision that rejected a series of applications to market fruit-flavored ...
Here's why school nurses need Texas law change to give new epi nasal spray to students
This is great news, but families can't just hand over the nasal spray form to their school nurse. The Texas law allowing ...