Jun 30
Implantable Marker Recall: Hologic Removes BioZorb 3D Bioabsorbable Markers due to Risk for Patient Complications
Medical Devices
For Health Professionals
FDA Collaborates with Health Professional Societies, Trade Associations, and Academia
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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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FDA VOICES: PERSPECTIVES FROM FDA EXPERTS
Lessons Learned from our Roundtable with Rare Disease Advocates
Recently FDA leadership held a roundtable discussion with 15 dedicated rare disease leaders.
Ensuring Quality and Access: FDA’s Approach to Generic Drug Oversight
FDA continues to prioritize the speed and efficiency with which generic drugs are regulated, balancing the need for minimizing risk and ensuring access.
Fifty Years of the Medical Device Amendments: Building on a Strong Foundation to Advance Safe, Effective and High-Quality Medical Devices
For five decades, the 1976 Amendments have served as the foundation of a regulatory framework designed to protect patients.
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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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