Black box warnings are the FDA’s bluntest regulatory instrument short of a recall. Yet despite what headlines, pundits, and influencers often suggest, they are neither a moral verdict nor the final ...

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 FDA has been rumored to be evaluating whether or not to place a black box warning on vaccines for COVID-19.

Black box warnings, or boxed warnings, are serious warnings that come from the FDA. They are meant to alert people about drug effects that may be dangerous. Specific drugs may carry a boxed warning, ...

The FDA plans to remove the black box warning from HRT, citing updated scientific evidence and expert collaboration. The decision aims to improve access to HRT by removing warnings about ...

The FDA’s removal of the black box warning from hormone therapy products acknowledges decades of evolving evidence and could help millions of women seek relief safely. The U.S. Food and Drug ...

(THE CONVERSATION) A “black box” warning on a health product sounds pretty scary – maybe even more so when it’s suddenly being taken off the packaging. Black box warnings – or as the FDA officially ...