The Food and Drug Administration approved on Friday a label change for Pfizer's birth control shot Depo-Provera that warns ...

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 ...

The FDA is removing a long-standing warning from hormone-based drugs used to treat menopause symptoms in women. FDA and HHS officials said the labels stemmed from a study published more than 20 years ...

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

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

The FDA sent a letter to manufacturers of dietary supplements proposing a reduction in required warning labels.

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 ...

FDA approves Depo-Provera label warning of meningioma brain tumor risk after 1983 studies; 1,000+ women sue Pfizer for ...

A label begins with highlights, a succinct, half-page summary of the information that health care practitioners most commonly refer to and view as most important (Figure 2). [4] This section provides ...