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256 articles found
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FDA Roundup: October 4, 2024Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Monday, Oct. 7, the Science Board to the FDA will convene to receive an update fro... -
FDA’s Unified Human Foods Program, New Model for Field Operations, and Other Modernization Efforts Go into EffectThe U.S. Food and Drug Administration, the oldest comprehensive consumer protection agency in the country, is marking a new chapter. For more than a century the FDA has, among other things, had the re...
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FDA Roundup: October 1, 2024Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA announced seven new clinical trial grants awarded in fiscal year (FY)...
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FDA Roundup: September 27, 2024Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA updated the Mycotoxins in Domestic and Imported Human Foods Comp...
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FDA Roundup: September 24, 2024Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA held a ribbon-cutting ceremony to highlight the completion of the 64,0...
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FDA Approves Nasal Spray Influenza Vaccine for Self- or Caregiver-AdministrationToday, the U.S. Food and Drug Administration approved FluMist for self- or caregiver-administration. FluMist is approved for the prevention of influenza disease caused by influenza virus subtypes A an...
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FDA Approves First Treatment for Niemann-Pick Disease, Type CToday, the U.S. Food and Drug Administration approved Miplyffa (arimoclomol), an oral medication for the treatment of Niemann-Pick disease, type C (NPC). Miplyffa, in combination with the enzyme inhib...
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FDA Roundup: September 20, 2024Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA and NIH announced “Advancing Smoking Cessation: FDA and NIH Priorities...
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FDA Roundup: September 17, 2024Today, 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 draft guidance, “Integrating Randomized Controlled Trials for...
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FDA Issues Draft Guidance on Conducting Multiregional Clinical Trials in OncologyToday, the U.S. Food and Drug Administration issued a draft guidance for industry that, when finalized, will provide sponsors with recommendations for conducting multiregional clinical trials (MRCT) i...