FDA Plans to Remove Black Box Warning on HRT 🚨
FDA experts discuss plans to eliminate the black box warning on hormone replacement therapy, signaling potential changes in safety guidelines.

U.S. Food and Drug Administration
1.0K views • Nov 14, 2025

About this video
FDA Commissioner and subject matter experts from the Center for Drug Evaluation and Research discuss the agency's recent announcement regarding removal of the “black box warning” for hormone replacement therapy.
Speakers include:
• Marty Makary, M.D., M.P.H., Commissioner of Food and Drug Administration
• Christine Nguyen, M.D., Deputy Director, Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, Office of New Drugs, Center for Drug Evaluation and Research
• Christina Chang, M.D., M.P.H., Division Director, Division of Urology, Obstetrics and Gynecology, Office of New Drugs, Center for Drug Evaluation and Research
• Sanjula Jain-Nagpal, Ph.D, Deputy Chief of Staff, Office of the Commissioner
• Dayle Cristinzio, Director, Office of External Affairs, Public Engagement Staff
Additional Resources:
• HHS Advances Women’s Health, Removes Misleading FDA Warnings on Hormone Replacement Therapy | FDA : https://www.fda.gov/news-events/press-announcements/hhs-advances-womens-health-removes-misleading-fda-warnings-hormone-replacement-therapy
• FDA Requests Labeling Changes Related to Safety Information to Clarify the Benefit/Risk Considerations for Menopausal Hormone Therapies | FDA : https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-labeling-changes-related-safety-information-clarify-benefitrisk-considerations
• FACT SHEET: FDA Initiates Removal of “Black Box” Warnings from Menopausal Hormone Replacement Therapy Products | HHS.gov : https://www.hhs.gov/press-room/fact-sheet-fda-initiates-removal-of-black-box-warnings-from-menopausal-hormone-replacement-therapy-products.html
Speakers include:
• Marty Makary, M.D., M.P.H., Commissioner of Food and Drug Administration
• Christine Nguyen, M.D., Deputy Director, Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, Office of New Drugs, Center for Drug Evaluation and Research
• Christina Chang, M.D., M.P.H., Division Director, Division of Urology, Obstetrics and Gynecology, Office of New Drugs, Center for Drug Evaluation and Research
• Sanjula Jain-Nagpal, Ph.D, Deputy Chief of Staff, Office of the Commissioner
• Dayle Cristinzio, Director, Office of External Affairs, Public Engagement Staff
Additional Resources:
• HHS Advances Women’s Health, Removes Misleading FDA Warnings on Hormone Replacement Therapy | FDA : https://www.fda.gov/news-events/press-announcements/hhs-advances-womens-health-removes-misleading-fda-warnings-hormone-replacement-therapy
• FDA Requests Labeling Changes Related to Safety Information to Clarify the Benefit/Risk Considerations for Menopausal Hormone Therapies | FDA : https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-labeling-changes-related-safety-information-clarify-benefitrisk-considerations
• FACT SHEET: FDA Initiates Removal of “Black Box” Warnings from Menopausal Hormone Replacement Therapy Products | HHS.gov : https://www.hhs.gov/press-room/fact-sheet-fda-initiates-removal-of-black-box-warnings-from-menopausal-hormone-replacement-therapy-products.html
Video Information
Views
1.0K
Duration
42:32
Published
Nov 14, 2025
User Reviews
3.7
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