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911 articles found
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FDA Roundup: March 31, 2023Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: This week, the FDA approved three first-time generic animal drugs, bringing additional... -
FDA Approves First Over-the-Counter Naloxone Nasal SprayToday, the U.S. Food and Drug Administration approved Narcan, 4 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription, use – the first naloxone product approved...
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FDA Outlines Immediate National Strategy to Further Increase the Resiliency of the U.S. Infant Formula MarketToday, the U.S. Food and Drug Administration released a national strategy outlining actions the agency will take immediately to help ensure one of the nation’s most vulnerable populations continue to...
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FDA Roundup: March 28, 2023Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA released an Immediate National Strategy to Increase the Resiliency of th...
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FDA Works to Further Improve Nutrition, Reduce Diet-Related Chronic Disease with Dietary Guidance Statements on Food LabelsThe U.S. Food and Drug Administration today issued draft guidance that provides food manufacturers with recommendations on how and when to use Dietary Guidance Statements on the label of food products...
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FDA Issues Draft Guidance Aimed at Improving Oncology Clinical Trials for Accelerated ApprovalToday, the U.S. Food and Drug Administration issued draft guidance, Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics, regarding clinical trial design consideratio...
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FDA Takes Additional Steps to Improve Nutrition, Reduce Disease with Expanded Use of Salt Substitutes to Help Lower Sodium IntakeToday, the U.S. Food and Drug Administration proposed changes to the standards of identity (SOIs) for foods that include salt to permit the use of safe and suitable salt substitutes. The proposed rule...
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FDA Roundup: March 24, 2023Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA finalized two guidances: Transition Plan for Medical Devices That Fall W...
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FDA Roundup: March 21, 2023Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA completed its second pre-market consultation for a human food made from...
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FDA Denies Marketing of Two Vuse Solo Menthol E-Cigarette ProductsToday, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) for two menthol e-cigarette products currently marketed by R.J. Reynolds Vapor Company under the Vuse Solo brand. The...