Published in 2024, the FDA’s ‘Final Rule’ outlined plans to subject lab-developed tests to the same requirements as medical ...

The U.S. Department of Agriculture's Food Safety and Inspection Service announced last week about 212,000 pounds of liquid ...

The judge vacated the FDA’s final rule, which was strongly opposed by the laboratory industry, and remanded the matter to HHS ...

The FDA has long believed it has the power to regulate lab-developed tests, but it only put out the rules under former ...

Mass firings and forced resignations sweep through the U.S. Food and Drug Administration under a new directive from the ...

Last year, the U.S. Food and Drug Administration approved Neffy, a nasal spray form of epinephrine for people who weigh 66 ...

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its ...

Dr. Peter Marks, a veteran of the agency, wrote that undermining confidence in vaccines is irresponsible and a danger to ...

The top vaccine official with the Food and Drug Administration has resigned and criticized the nation's top health official ...

The FDA has approved a new drug for a serious heart condition that affects thousands of people. The drug, called Amvuttra ...