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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 MoreRecalls, 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 17
“Jeni’s Splendid Ice Cream Voluntarily Recalls Passion Fruit Dreamsicle Ice Cream Bars Due to Undeclared Wheat and Soy.”
Food & Beverages
Nov 14
Face Rock Creamery LLC Recalls 6oz. Vampire Slayer Garlic Cheddar Because of Possible Health Risk
Food & Beverages
Nov 12
Food To Live Voluntarily Recalls Organic Moringa Products Because of Possible Health Risk
Food & Beverages
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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 17
Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use
Drugs
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