The FDA has long believed it has the power to regulate lab-developed tests, but it only put out the rules under former ...
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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 ...
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 ...
The US Food and Drug Administration has delayed granting full approval of Novavax’s Covid-19 vaccine despite it being on ...
The judge vacated the FDA’s final rule, which was strongly opposed by the laboratory industry, and remanded the matter to HHS ...
A federal judge in Texas has blocked the FDA’s plans to bring laboratory-developed tests under the same regulations it uses ...
Yesterday, the U.S. District Court for the Eastern District of Texas vacated the U.S. Food and Drug Administration’s 2024 rule that aimed to ...
A federal judge ruled Monday that the FDA doesn’t have the legal authority to regulate lab-developed tests, dealing a blow to ...
The U.S. District Court for the Eastern District of Texas March 31 ruled that the Food and Drug Administration does not have ...
Fresh Creative Foods is voluntarily recalling Trader Joe’s Hot Honey Mustard Dressing because of an incorrect label.
The U.S. Department of Agriculture's Food Safety and Inspection Service announced last week about 212,000 pounds of liquid ...
The U.S. Supreme Court on Wednesday upheld an FDA decision that rejected a series of applications to market fruit-flavored ...