The judge vacated the FDA’s final rule, which was strongly opposed by the laboratory industry, and remanded the matter to HHS ...
Published in 2024, the FDA’s ‘Final Rule’ outlined plans to subject lab-developed tests to the same requirements as medical ...
The FDA has long believed it has the power to regulate lab-developed tests, but it only put out the rules under former ...
The U.S. Department of Agriculture's Food Safety and Inspection Service announced last week about 212,000 pounds of liquid ...
A federal judge in Texas has blocked the FDA’s plans to bring laboratory-developed tests under the same regulations it uses ...
A federal judge in Texas has ruled that the FDA does not have the authority to regulate laboratory developed tests as medical ...
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its ...
Dr. Peter Marks, the top vaccine regulator at the U.S. Food and Drug Administration, was forced to resign, citing Health and ...
The top vaccine official with the Food and Drug Administration has resigned and criticized the nation's top health official ...
In May 2024, the U.S. Food & Drug Administration (“FDA” or the “Agency”) published its Final Rule establishing its regulatory ...
Sweeping cuts to federal health agencies have created uncertainty about the future of a variety of public health programs.
Mass firings and forced resignations sweep through the FDA under a new directive from the Trump administration, affecting ...