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 ...

The FDA is considering a rule change that would cut back on how often dietary supplement warnings must appear on packaging, a move experts say could make them easier to miss.

The Trump administration is expected to label COVID-19 vaccines with a warning about serious possible side effects. The Food and Drug Administration will likely put the agency’s most weighty “black ...

FDA approves Depo-Provera label warning of meningioma brain tumor risk after 1983 studies; 1,000+ women sue Pfizer for concealment as EMA, Canada already updated labels., US News, Times Now ...

FDA adds brain tumor warning to Depo-Provera label for Pfizer’s birth control injections after studies link the drug to meningioma risk.

(CNN) — Kenvue, the American company that makes Tylenol, says the US Food and Drug Administration should not make proposed changes to the product’s safety label to reflect research about a possible ...

America is in the midst of a pharmacy crisis, and the Food and Drug Administration could make it much worse. Hundreds of ...

A study found that 26% of uncertainties in cancer drug approvals are not included in FDA labels, with 48% being crucial to approval decisions. The FDA's current communication methods, such as drug ...

Kenvue, the American company that makes Tylenol, says the U.S. Food and Drug Administration should not make proposed changes to the product’s safety label to reflect research about a possible ...