GlobalData on MSN21h
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 ...
MedTech Dive17h
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 ...
FDA recalls 12-packs of Coca-Cola due to plastic contamination. See if Texas is affected
The FDA recalled 864 12-packs of Coca-Cola sold in two states earlier this month, and on Monday, the agency classified it as ...
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 ...
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 ...
Fierce Biotech17h
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 ...
American Hospital Association12h
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 ...
Food Safety News2d
FDA warns companies in California, Texas for failing to verify foreign suppliers
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its ...
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 ...
Becker's Hospital Review17h
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 ...
Measles outbreak worsens as Texas cases rise 20% in 3 days
The Texas health department said on Friday that the number of measles cases in the state rose 20% since its last report three ...
Peter Marks, top FDA vaccine official, forced to resign
Dr. Peter Marks, the top vaccine regulator at the U.S. Food and Drug Administration, was forced to resign, citing Health and ...