Initiating the Removal of the “Black Box Warning” on Hormone Replacement Therapy
U.S. Food and Drug Administration (FDA) · November 14, 2025
FDA officials announced this week that the agency has asked manufacturers to remove longstanding boxed warnings from estrogen-containing hormone replacement therapy labels, saying a review of recent and older evidence and public input no longer supports blanket black-box language; agency officials outlined the proposed labeling changes and answered questions about timing and evidence.
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