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911 articles found
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FDA Authorizes Marketing of 20 ZYN Nicotine Pouch Products after Extensive Scientific ReviewToday, the U.S. Food and Drug Administration authorized the marketing of 20 ZYN nicotine pouch products through the premarket tobacco product application (PMTA) pathway following an extensive scientif... -
FDA Proposes Significant Step Toward Reducing Nicotine to Minimally or Nonaddictive Level in Cigarettes and Certain Other Combusted Tobacco ProductsToday, the U.S. Food and Drug Administration issued a proposed rule that, if finalized, would make cigarettes and certain other combusted tobacco products minimally or nonaddictive by limiting the lev...
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FDA Proposes Requiring At-a-Glance Nutrition Information on the Front of Packaged FoodsImage Today, the U.S. Food...
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FDA Roundup: January 14, 2025Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:Today, the FDA issued a Request for Information (RFI) on industry practices related to p...
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FDA Roundup: January 10, 2025Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:Today the FDA released a Long-Term National Strategy to Increase the Resiliency of the U...
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FDA Issues Draft Guidance on Including Tissue Biopsies in Clinical TrialsToday, the U.S. Food and Drug Administration issued a draft guidance with the Office for Human Research Protections that, when finalized, will provide recommendations for including tissue biopsies as...
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FDA Proposes Framework to Advance Credibility of AI Models Used for Drug and Biological Product SubmissionsToday, the U.S. Food and Drug Administration issued draft guidance to provide recommendations on the use of artificial intelligence (AI) intended to support a regulatory decision about a drug or biolo...
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FDA Issues Comprehensive Draft Guidance for Developers of Artificial Intelligence-Enabled Medical DevicesToday, the U.S. Food and Drug Administration issued draft guidance that includes recommendations to support development and marketing of safe and effective AI-enabled devices throughout the device’s T...
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FDA Proposes Updated Recommendations to Help Improve Performance of Pulse Oximeters Across Skin TonesToday, the U.S. Food and Drug Administration published new draft guidance aimed at helping improve the accuracy and performance of pulse oximeters – important devices for patient care that are used to...
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FDA Roundup: January 3, 2025Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:Today, the FDA issued a notice in the Federal Register with its determination that 35 fo...