The FDA is reportedly considering the addition of high-level warning labels to COVID vaccines, a move that some experts say ...

Black box warnings are the FDA’s bluntest regulatory instrument short of a recall. Yet despite what headlines, pundits, and ...

The U.S. Food and Drug Administration intends to put a "black box" warning on COVID-19 vaccines, CNN reported on Friday, ...

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 ...

Officials said they were considering such a move last week, but the plan was widely condemned by health experts.

The US Food and Drug Administration intends to put a “black box” warning on Covid-19 vaccines, according to two people familiar with the agency’s plans.

Commissioner Marty Makary on Monday denied recent reports suggesting plans for his agency to add a black box warning to COVID ...

The US Food and Drug Administration has no plans to put a “black box” warning on Covid vaccines, the agency’s top official ...

The FDA plans to add a “black-box warning” to COVID-19 vaccines — that’s the strongest warning the agency can issue. But Will ...

FDA plans possible black box warning for COVID-19 shots amid rare heart risk reports; studies say the virus carries a higher ...

The FDA intends to place a black box label—its most serious warning—on COVID-19 vaccines, according to reporting by CNN. It ...