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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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Transparency Makes Modern Regulatory Science Stronger — FDA’s Transparency Roadmap
FDA is taking a bold step to reinforce its commitment to transparency by releasing this new FDA Transparency Roadmap.
An America First Approach to Medical Innovation
The FDA’s new Expedited IND Pilot will cut unnecessary delays in early-stage clinical research without compromising patient safety
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.
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United States
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