Feb 25
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Initiating the Removal of the “Black Box Warning” on Hormone Replacement Therapy
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Initiating the Removal of the “Black Box Warning” on Hormone Replacement Therapy
November 12, 2025 - FDA Commissioner and subject matter experts from the Center for Drug Evaluation and Research discussed the agency's recent announcement regarding the removal of the "black box warning" for hormone replacement therapy.
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Office of External Affairs
Office of the Commissioner
Food and Drug Administration
10903 New Hampshire Ave WO32-5367
Silver Spring, MD 20993
United States
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Public Engagement Staff
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