The FDA has long believed it has the power to regulate lab-developed tests, but it only put out the rules under former ...
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 ...
Last year, the U.S. Food and Drug Administration approved Neffy, a nasal spray form of epinephrine for people who weigh 66 ...
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 set aside, in ...
Sweeping cuts to federal health agencies have created uncertainty about the future of a variety of public health programs.
The Food and Drug Administration, responsible for setting standards for Americans’ foods and medications, will shed 3,500 ...
Employees of the massive U.S. Department of Health and Human Services began getting dismissal notices in a major overhaul expected to ultimately lay off up to 10,000 people​.
Asthma doctors say the move will put their patients at risk of life-threatening reactions when they take the drugs at home.
Health and Human Services Secretary Robert F. Kennedy will cut 3,500 jobs from the Food and Drug Administration, according to the fact sheet. "This reduction will not affect drug, medical device ...