Commissioner Marty Makary on Monday denied recent reports suggesting plans for his agency to add a black box warning to COVID-19 vaccines. CNN reported last week that the FDA was considering adding a ...

A black-box warning is not a neutral informational update. It is the FDA’s most aggressive regulatory communication via product labeling, intended to alert clinicians and patients to risks so grave ...

The US Food and Drug Administration has no plans to put a “black box” warning on Covid vaccines, the agency’s top official said, despite a recent report that US regulators were preparing to add a new ...

A "black box" warning on a health product sounds pretty scary—maybe even more so when it's suddenly being taken off the packaging. Subscribe to our newsletter for the latest sci-tech news updates.

A boxed warning, or black box warning, is the most serious warning issued by the Food and Drug Administration (FDA). Its purpose is to alert people about drug effects that may be dangerous. Boxed ...