The U.S. Food and Drug Administration will remove the “black box” warning labels on many hormone therapy drugs used for menopause and perimenopause symptoms — a major turnaround that’s likely to ...
Marking a pivotal moment in women’s health, the U.S. Food and Drug Administration (FDA) on Monday initiated actions to remove “black box” warnings, the agency’s strongest safety alert, from hormone ...
The U.S. Food and Drug Administration (FDA) announced today that it’s recommending the removal of black-box warnings, the agency’s highest warning for prescription medications, from all hormone ...
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 ...
Hormone therapy was thrust back into the spotlight today after Food and Drug Administration Commissioner Marty Makary, MD, convened a panel that he hoped would “set the record straight” about its use ...
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 U.S. Food and Drug Administration has removed the “black box” safety warning from most hormone therapies used to treat menopause symptoms, ending a 20-year era of caution that began after the ...