Apr 16
Windstone Medical Packaging dba Aligned Medical Solutions Issues Nationwide Recall of Namic Angiographic Rotating Adapter 10CC Control Syringe Placed into the Following Kits; AMS6908E Angio Pack, and AMS6908F Angio Pack
Medical Devices
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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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Medical Devices
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FDA VOICES: PERSPECTIVES FROM FDA EXPERTS
FDA Scientists Working in Satellite Laboratories Across U.S. Help Prevent Harmful Drugs from Reaching Americans
FDA has satellite laboratories stationed inside high-volume international mail facilities at airports in Chicago, New York, Los Angeles, Miami—and now Honolulu.
Real-World Evidence: Advancing Regulatory Decision-Making for Medical Devices
The FDA has published a new set of 73 examples of marketing authorizations using RWE from FY2020-2025.
Why Protecting Confidential Information is Key to the FDA’s "Gold Standard"
The FDA must maintain a delicate balance: being a model of openness regarding the scientific basis of its decisions, while safeguarding proprietary information.
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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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