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FDA News

 

Recent news from the US Food and Drug Administration. Click title to see the full article at the FDA website. For the most up-to-date headlines, check out the FDA Newsroom. Press announcements from 2004 to 2009 are available through the FDA Archive.

FDA Recalls: FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company. This site does not contain a complete list of recalls - search for recalls at the official FDA site.

 

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March 2025

March 28, 2025 - FDA Approves Novel Treatment for Hemophilia A or B, with or without Factor Inhibitors
March 28, 2025 - FDA Roundup: March 28, 2025
March 28, 2025 - FDA Grants Marketing Authorization of First Home Test for Chlamydia, Gonorrhea and Trichomoniasis
March 21, 2025 - FDA Roundup: March 21, 2025
March 20, 2025 - HHS, FDA Announce Chemical Contaminants Transparency Tool for Foods
March 18, 2025 - HHS, FDA Announce Operation Stork Speed to Expand Options for Safe, Reliable, and Nutritious Infant Formula for American Families
March 18, 2025 - FDA Roundup: March 18, 2025
March 14, 2025 - FDA Educational Efforts Prevented Nearly 450,000 Youth from Starting E-Cigarette Use in One Year
March 14, 2025 - FDA Roundup: March 14, 2025
March 11, 2025 - FDA Roundup: March 11, 2025
March 7, 2025 - FDA Roundup: March 7, 2025
March 4, 2025 - FDA Roundup: March 4, 2025

 

February 2025

February 28, 2025 - FDA Roundup: February 28, 2025
February 21, 2025 - FDA Approves First Treatment for Cerebrotendinous Xanthomatosis, a Rare Lipid Storage Disease
February 14, 2025 - FDA Approves First Rapid-Acting Insulin Biosimilar Product for Treatment of Diabetes
February 5, 2025 - FDA Alerts Patients of Potential to Miss Critical Safety Alerts Due to Phone Settings When Using Smartphone-Compatible Diabetes Devices

 

January 2025

January 30, 2025 - FDA Approves Novel Non-Opioid Treatment for Moderate to Severe Acute Pain
January 17, 2025 - FDA Roundup: January 17, 2025
January 16, 2025 - FDA Authorizes Marketing of 20 ZYN Nicotine Pouch Products after Extensive Scientific Review
January 15, 2025 - FDA Proposes Significant Step Toward Reducing Nicotine to Minimally or Nonaddictive Level in Cigarettes and Certain Other Combusted Tobacco Products
January 14, 2025 - FDA Proposes Requiring At-a-Glance Nutrition Information on the Front of Packaged Foods
January 14, 2025 - FDA Roundup: January 14, 2025
January 10, 2025 - FDA Roundup: January 10, 2025
January 7, 2025 - FDA Roundup: January 7, 2025
January 6, 2025 - FDA Issues Draft Guidance on Including Tissue Biopsies in Clinical Trials
January 6, 2025 - FDA Proposes Framework to Advance Credibility of AI Models Used for Drug and Biological Product Submissions
January 6, 2025 - FDA Issues Comprehensive Draft Guidance for Developers of Artificial Intelligence-Enabled Medical Devices
January 6, 2025 - FDA Proposes Updated Recommendations to Help Improve Performance of Pulse Oximeters Across Skin Tones
January 3, 2025 - FDA Roundup: January 3, 2025

 

December 2024

December 27, 2024 - FDA Roundup: December 27, 2024
December 26, 2024 - FDA Proposes Rule to Require Standardized Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products
December 23, 2024 - FDA Approves First Generic of Once-Daily GLP-1 Injection to Lower Blood Sugar in Patients with Type 2 Diabetes
December 20, 2024 - FDA Approves First Medication for Obstructive Sleep Apnea
December 20, 2024 - FDA Approves First Acellular Tissue Engineered Vessel to Treat Vascular Trauma in Extremities
December 20, 2024 - FDA Roundup: December 20, 2024
December 19, 2024 - FDA Updates “Healthy” Claim, Providing a Refreshed Tool for Consumers
December 18, 2024 - FDA Approves First Mesenchymal Stromal Cell Therapy to Treat Steroid-refractory Acute Graft-versus-host Disease
December 17, 2024 - FDA Roundup: December 17, 2024
December 13, 2024 - FDA Approves New Treatment for Congenital Adrenal Hyperplasia
December 13, 2024 - FDA Roundup: December 13, 2024
December 10, 2024 - FDA Roundup: December 10, 2024

December 6, 2024 - FDA Roundup: December 6, 2024

December 3, 2024 - USDA-FDA Seek Information About Food Date Labeling, Aim is to Provide Further Clarity, Transparency and Cost Savings for U.S. Consumers
December 3, 2024 - FDA Roundup: December 3, 2024

 

MedSun Newsletters

See the current MedSun newsletter at the FDA website for Recalls and Safety Alerts, Highlighted Reports, and Links to FDA/CDRH Databases and Other Information Sources.

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