FDA

The FDA considers plants that have gone more than five years without an inspection to be a significant risk. Officials say the work has been hampered by difficulties recruiting and retaining inspectors.

USF allergist Dr. Thomas Casale told an FDA advisory panel last year. that of the 6 million prescriptions written for EpiPen auto-injectors each year, more than 40% are never filled.

The story of MitraClip, a device Dr. Oz helped invent to treat faulty heart valves, is a cautionary tale about the science, business and regulation of medical technology.

The questionable imaging tests by North Shore Medical Center were done between March 2022 and March 2024. The facility is owned by Steward Health Care, which is undergoing Chapter 11 bankruptcy.

Advisers ultimately said sticking with JN.1 rather than its offshoots promises to offer a better chance at cross-protection. The FDA will decide the final recipe soon.

Mounting evidence suggests psychoactive drugs including LSD, ketamine, mushrooms and MDMA can be powerful treatments for severe depression and PTSD. But not everyone is convinced.

Johns Dental Laboratories stopped making the appliance last year after a KFF Health News-CBS News investigation into allegations of patient harm. The company had “never” reported any complaints about its products to the FDA, according to the agency.

Some pumps used in end-stage heart failure caused a buildup of biological material that blocks blood flow from the device to the heart’s aorta. The FDA’s recall affects nearly 14,000 devices.

Menthols are disproportionately used by Black smokers and young people. Supporters of the plan have tried to assure the White House that a ban will not hurt the president's reelection chances.

The EPA is tightening regulation of ethylene oxide, a carcinogenic gas used to sterilize medical devices. The agency is trying to balance the interests of the health care industry supply chain with those of communities where the gas creates airborne health risks.

Researchers have externally attached a pig liver to a brain-dead human and watched it successfully filter blood. The experiment is a step toward one day trying the technique in patients with liver failure.

Health officials say a preliminary review finds no connection between suicidal thoughts and a new class of diabetes and obesity drugs, but they cannot definitively rule out “a small risk may exist."