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FDA Lapse in Funding
Mission-critical activities of FDA will continue during the Democrat-led government shutdown. Please use this site as a resource as the Trump Administration works to reopen the government for the American people.
FDA Accomplishments for the American People
Recent Press Announcements
Recalls, Market Withdrawals, & Safety Alerts
Alerting you to the latest recalls of potentially unsafe FDA-regulated products gathered from press releases and other public notices. Not all recalls have press releases or are posted on this website.
Nov 03
Dreyer's Grand Ice Cream, Inc. Issues Allergy Alert on Undeclared Wheat in Haagen-Dazs Chocolate Dark Chocolate Mini Bars in 6 Count Pack
Food & Beverages
Oct 31
Olympus Issues Voluntary Labeling Update for Bronchoscopes Used with Laser Therapy Equipment
Medical Devices
Oct 31
Otsuka ICU Medical LLC Issues Voluntary Nationwide Recall of 20 mEq Potassium Chloride Injection Due To Overwrap Mislabeled As 10 mEq Potassium Chloride Injection
Drugs
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FDA VOICES: PERSPECTIVES FROM FDA EXPERTS
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.
FDA Focuses on Closing the Clinical Trial Reporting Gap for Research Integrity
The FDA is committed to ensuring data transparency by promoting timely registration and reporting of results information to ClinicalTrials.gov.
FDA Advances Drug Development Innovation by Establishing ISTAND as Permanent Qualification Program
ISTAND supports innovative, science-driven approaches that improve drug development and regulatory decision-making.
Recently Published Guidances
Oct 29
Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies
Drugs
Oct 28
Menstrual Products – Performance Testing and Labeling Recommendations
Medical Devices
Oct 27
Quality Management System Information for Certain Premarket Submission Reviews
Medical Devices