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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
HHS Advances Women’s Health, Removes Misleading FDA Warnings on Hormone Replacement Therapy
The U.S. Department of Health and Human Services (HHS) today announced historic action to restore gold-standard science to women’s health.
Read MoreRecent 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 08
Moonlight Companies Voluntarily Recalls California-Grown Conventional Yellow and White Peaches Because of Possible Health Risk- Revised to Clarify Upc Codes; This Recall Has Not Been Expanded
Food & Beverages
Nov 08
In Response to a Broader FDA Investigation, ByHeart Initiates a Voluntary Recall of Two Batches of Infant Formula
Food & Beverages
Nov 06
Fresenius Kabi Issues Voluntary Nationwide Recall of Three Lots of Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL Fill in a 2 mL Vial Due to Out-of-Specification Endotoxin Results in Certain Reserve Samples
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
Nov 06
How to Prepare a Pre-Request for Designation (Pre-RFD)
Biologics, Drugs, Medical Devices
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