Mar 18
Early Alert: Surgical Stapler Issue from Intuitive Surgical
Medical Devices
For Health Professionals
FDA Collaborates with Health Professional Societies, Trade Associations, and Academia
Topic Paragraphs
Call-To-Action Title
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.
View Recording
Subscribe to our e-newsletter
We know you're busy! The easiest way to keep up with us is to subscribe to our weekly e-newsletter.
You'll get the latest announcements, regulations, and upcoming events delivered to your email inbox every Monday.
How to Report Adverse Events to FDA MedWatch
Health professionals, consumers and patients can voluntarily report observed or suspected adverse events for human medical products to FDA. Voluntary reporting can help FDA identify unknown risk for approved medical products.
Learn MoreMedWatch Safety Alerts
May 26
Ocaliva (obeticholic acid) by Intercept Pharmaceuticals: Drug Safety Communication - Due to Risk of Serious Liver Injury, FDA Restricts Use of Ocaliva in Primary Biliary Cholangitis Patients with Advanced Cirrhosis
Drugs
Sep 23
Benzodiazepine Drug Class: Drug Safety Communication - Boxed Warning Updated to Improve Safe Use
Drugs
Paragraph Header
FDA VOICES: PERSPECTIVES FROM FDA EXPERTS
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.
A Special Year, New Seal, and Renewed Commitment to the American People
The FDA has unveiled an official agency seal which signifies the many public health strides made over 120 years.
FDA Encourages Development of New, Reliable Alternatives to Animal Testing in Sunscreen
FDA strongly encourages companies to continue to develop new, reliable ways to minimize animal testing.
Reach out today to talk about collaborating!
Public Engagement Staff
Office of External Affairs
Office of the Commissioner
Food and Drug Administration
10903 New Hampshire Ave WO32-5367
Silver Spring, MD 20993
United States
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
Paragraph Header (Column 2)
MedWatch Safety Alerts on X:
Paragraph Header (Column 2)
MedWatch Safety Alerts on X:
MedWatch
FDA MedWatch Safety Information
You know the moment it happens.
Follow @FDAMedWatch