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911 articles found
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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... -
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Development of Novel Therapies for Stimulant Use DisordersToday, the U.S. Food and Drug Administration published a new draft guidance to assist sponsors in developing treatments for stimulant use disorders.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...
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FDA Roundup: October 3, 2023Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA, in partnership with the University of Maryland Center of Excellence in...
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FDA Launches Pilot Program to Help Further Accelerate Development of Rare Disease TherapiesToday, the U.S. Food and Drug Administration is taking steps to help further accelerate the development of novel drug and biological products for rare diseases. The agency is announcing the opportunit...