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278 articles found
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FDA Warns Nine Manufacturers, Distributors of Unapproved Antimicrobials for AnimalsToday, the U.S. Food and Drug Administration is announcing the issuance of nine warning letters to manufacturers and distributors of unapproved and misbranded antimicrobial animal drugs for violations... -
FDA Advances Reorganization Proposal for Unified Human Foods Program, Field Operations and Additional Modernization EffortsToday, the U.S. Food and Drug Administration is providing an update on its efforts to create a unified Human Foods Program (HFP) and new Office of Regulatory Affairs (ORA) model, including additional...
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FDA Creates New Advisory Committee for Evaluation of Genetic Metabolic Disease TreatmentsToday, the U.S. Food and Drug Administration announced it is creating a new advisory committee related to potential treatments for genetic metabolic diseases.Genetic metabolic diseases are conditions...
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FDA Approves First Gene Therapies to Treat Patients with Sickle Cell DiseaseToday, the U.S. Food and Drug Administration approved two milestone treatments, Casgevy and Lyfgenia, representing the first cell-based gene therapies for the treatment of sickle cell disease (SCD) in...
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FDA Roundup: December 8, 2023Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Wednesday, the FDA announced that eSTAR is now available for voluntary use for certa...
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FDA, USDA and EPA Propose National Strategy to Reduce U.S. Food Loss and WasteThe U.S. Food and Drug Administration, the U.S. Department of Agriculture (USDA) and the U.S. Environmental Protection Agency (EPA) released a national strategy that will drive progress toward the nat...
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FDA Cautions Public of Safety Issue with Philips’ DreamStation 2 CPAP MachinesToday, as part of the U.S. Food and Drug Administration’s continued commitment to protect and promote the public health, the agency is alerting patients and healthcare providers of an emerging safety...
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FDA Roundup: November 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 issued a safety communication to provide additional information about th...
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Federal Court Enters Consent Decree Against Arizona-based Company for Distribution of Unapproved Contraceptive DrugsToday, the U.S. District Court for the District of Arizona entered a consent decree of permanent injunction ordering Smart Women’s Choice, Inc., an Arizona-based company, and Jennifer A. Richard, its...
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FDA Roundup: November 14, 2023Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Monday, the FDA updated the advisory for the Investigation of Elevated Lead Levels i...