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278 articles found
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FDA Roundup: October 24, 2023Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Friday, the FDA approved Medtronic’s Aurora EV-ICD System for the treatment of patie... -
FDA Roundup: October 20, 2023Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA announced the fiscal year (FY) 2024 fee rates and payment procedures for...
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FDA Deputy Commissioner for Human Foods Commits to Fulfilling Vision of Proposed ProgramEarlier this year, U.S. Food and Drug Administration Commissioner Robert M. Califf, M.D. laid out a bold vision to transform the agency’s human foods enterprise. I am thrilled to have joined the FDA l...
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FDA Roundup: October 17, 2023Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA’s The Center for Drug Evaluation and Research (CDER) announced that the...
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FDA Roundup: October 13, 2023Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: The FDA Oncology Center of Excellence (OCE) in conjunction with the European Medicines...
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FDA Denies Marketing of Six Flavored Vuse Alto E-Cigarette Products Following Determination They Do Not Meet Public Health StandardToday, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) to R.J. Reynolds Vapor Company for six flavored e-cigarette products under its Vuse Alto brand. This includes three m...
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FDA Establishes New Advisory Committee on Digital Health TechnologiesToday, the U.S. Food and Drug Administration announced the creation of a new Digital Health Advisory Committee to help the agency explore the complex, scientific and technical issues related to digita...
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FDA Roundup: October 6, 2023Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA updated its infant formula compliance program for FDA investigators, lab...
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FDA Takes Steps to Advance the Development of Novel Therapies for Stimulant Use DisordersToday, the U.S. Food and Drug Administration published a new draft guidance to assist sponsors in developing treatments for stimulant use disorders. The guidance, Stimulant Use Disorders: Developing D...
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FDA Authorizes Updated Novavax COVID-19 Vaccine Formulated to Better Protect Against Currently Circulating VariantsToday, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) of the Novavax COVID-19 Vaccine, Adjuvanted for use in individuals 12 years of age and older to include the 2...