Sep 03
B. Braun Medical Inc. Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container Due to the Presence of Particulate Matter
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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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Sep 03
Spinal Cord Stimulator Recall: Boston Scientific Removes Infinion CX Lead
Medical Devices
Sep 03
Early Alert: Heart Pump Controller Purge Cassette Issue from Abiomed
Medical Devices
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FDA VOICES: PERSPECTIVES FROM FDA EXPERTS
Good Clinical Practices Are Not Optional: The FDA’s Commitment to Human Subject Protections and Gold Standard Science in an Era of Global Clinical Research
The FDA’s position is clear: GCP is not bureaucratic formality. It is the scientific and ethical foundation on which our regulatory decisions rest.
FDA Weighs in on the Development and Use of Digitally Derived Measures for Clinical Investigations
Unlocking the Full Potential of Digital Health Technologies to Support Medical Product Development and Innovation
America Must Address Early Clinical Development
FDA is reimagining the IND Process Through Clarifying Requirements and Launching the Expedited IND Pilot.
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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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