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Food and Drug Administration--Press Releases

Get the latest updates from Food and Drug Administration--Press Releases directly as they happen.

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Last updated 5 days ago

FDA Approves Novel Non-Opioid Treatment for Moderate to Severe Acute Pain

5 days ago

The FDA approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid...

FDA Roundup: January 17, 2025

18 days ago

The U.S. Food and Drug Administration is providing an at-a-glance summary of...

FDA Authorizes Marketing of 20 ZYN Nicotine Pouch Products after Extensive Scientific Review

20 days ago

Today, the U.S. Food and Drug Administration authorized the marketing of 20...

FDA Roundup: January 14, 2025

22 days ago

The U.S. Food and Drug Administration is providing an at-a-glance summary of...

FDA Proposes Requiring At-a-Glance Nutrition Information on the Front of Packaged Foods

22 days ago

FDA announces a proposed rule requiring food manufacturers to display a front-of-package...

FDA Roundup: January 10, 2025

26 days ago

The U.S. Food and Drug Administration is providing an at-a-glance summary of...

FDA Roundup: January 7, 2025

28 days ago

The U.S. Food and Drug Administration is providing an at-a-glance summary of...

FDA Issues Draft Guidance on Including Tissue Biopsies in Clinical Trials

30 days ago

The FDA issued draft guidance that, when finalized, will provide recommendations for...

FDA Proposes Framework to Advance Credibility of AI Models Used for Drug and Biological Product Submissions

30 days ago

The FDA issued draft guidance to provide recommendations on the use of...

FDA Issues Comprehensive Draft Guidance for Developers of Artificial Intelligence-Enabled Medical Devices

30 days ago

Today, the U.S. Food and Drug Administration issued draft guidance that includes...

FDA Proposes Updated Recommendations to Help Improve Performance of Pulse Oximeters Across Skin Tones

30 days ago

The FDA published new draft guidance aimed at helping improve the accuracy...