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22 articles found
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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... -
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Development of Novel Therapies for Stimulant Use DisordersToday, the U.S. Food and Drug Administration published a new draft guidance to assist sponsors in developing treatments for stimulant use disorders.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...
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FDA Proposes Rule Aimed at Helping to Ensure Safety and Effectiveness of Laboratory Developed TestsToday, the U.S. Food and Drug Administration announced a proposed rule regarding laboratory developed tests, or LDTs, which play an important role in healthcare. The rule is aimed at helping to ensure...
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FDA Roundup: September 29, 2023Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA released a video titled “Importing FDA-Regulated Products: Human Foods”...
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FDA Seeks Fines Against 22 Retailers for Selling Illegal Youth-Appealing E-CigarettesThe U.S. Food and Drug Administration issued complaints for civil money penalties (CMPs) against 22 retailers for the illegal sale of Elf Bar/EB Design e-cigarettes, a popular youth-appealing brand. T...
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FDA Draft Guidance Could Result in Safer Food Options for People with Allergies to Sesame, Other Food AllergensToday, the U.S. Food and Drug Administration announced updated draft guidance designed to help food facilities comply with the requirements for current good manufacturing practices (CGMPs) and prevent...