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911 articles found
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Coronavirus (COVID-19) Update: FDA Authorizes Updated (Bivalent) COVID-19 Vaccines for Children Down to 6 Months of AgeToday, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the updated (bivalent) Moderna and Pfizer-BioNTech COVID-19 vaccines to include use in children down to... -
FDA Provides Update on External Evaluation to Strengthen Agency’s Human Foods ProgramIn July, I commissioned an external evaluation of the U.S. Food and Drug Administration’s Human Foods Program, including the Office of Food Policy and Response (OFPR), the Center for Food Safety and A...
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FDA Approves First Gene Therapy to Treat Adults with Hemophilia BToday, the U.S. Food and Drug Administration approved Hemgenix (etranacogene dezaparvovec), an adeno-associated virus vector-based gene therapy for the treatment of adults with Hemophilia B (congenita...
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FDA Warns Seven Companies for Selling Dietary Supplements with Claims to Treat Cardiovascular DiseaseToday, the U.S. Food and Drug Administration issued warning letters to seven companies for illegally selling dietary supplements that claim to cure, treat, mitigate or prevent cardiovascular disease o...
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FDA Spurs Innovation for Human Food from Animal Cell Culture TechnologyThe world is experiencing a food revolution and the U.S. Food and Drug Administration is committed to supporting innovation in the food supply. As an example of that commitment, today we are announcin...
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FDA Warns Firms for Selling Illegal E-cigarettes That Look Like Toys, Food, and Cartoon CharactersToday, the U.S. Food and Drug Administration issued warning letters to five firms for the unauthorized marketing of 15 different e-cigarette products. Each e-cigarette product is packaged to look like...
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FDA Mengalami Kemajuan di Era Baru Keamanan Pangan yang Lebih Cerdas, Memfinalisasi Aturan Dasar untuk Meningkatkan Keterlacakan Makanan TerkontaminasiHari ini, Badan Pengawas Obat dan Makanan AS mengumumkan kemajuan yang belum pernah terjadi sebelumnya dalam pencegahan penyakit yang ditularkan melalui makanan melalui finalisasi aturan untuk melacak...
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FDA Roundup: November 15, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued an Emergency Use Authorization (EUA) to Roche Molecular Systems...
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FDA Advances the New Era of Smarter Food Safety, Finalizing Foundational Rule to Improve Traceability of Contaminated FoodsToday, the U.S. Food and Drug Administration announced an unprecedented advancement in foodborne illness prevention through the finalization of a rule to more effectively trace contaminated food throu...
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FDA Conditionally Approves First Drug to Manage Acute Onset of Pancreatitis in DogsToday, the U.S. Food and Drug Administration conditionally approved Panoquell-CA1 (fuzapladib sodium for injection) for the management of clinical signs associated with acute onset of pancreatitis in...