May 21
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
Call-To-Action Title
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
How FDA is Implementing Landmark Cosmetics Legislation to Positively Impact Public Health
MoCRA expanded FDA’s authority over cosmetics and established new requirements for cosmetic companies and individuals who market cosmetics in the U.S.
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.
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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
Hours Available
Public Engagement Staff
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