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911 articles found
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FDA Roundup: November 22, 2024Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA published the FDA Voices: “Upholding Public Trust: FDA Office of... -
FDA Roundup: November 19, 2024Today, 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 request for information (RFI) on per- and polyfluoroalkyl sub...
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FDA Roundup: November 15, 2024Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Next week, the World Health Organization’s Member State Mechanism on Substandard and...
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FDA Approves First Gene Therapy for Treatment of Aromatic L-amino Acid Decarboxylase DeficiencyThe U.S. Food and Drug Administration approved Kebilidi (eladocagene exuparvovec-tneq), an adeno-associated virus vector-based gene therapy indicated for the treatment of adult and pediatric patients...
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FDA Roundup: November 8, 2024Today, 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 final rule, to amend the color additive regulations to increa...
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FDA Proposes Ending Use of Oral Phenylephrine as OTC Monograph Nasal Decongestant Active Ingredient After Extensive ReviewToday, the U.S. Food and Drug Administration announced it is proposing to remove oral phenylephrine as an active ingredient that can be used in over-the-counter (OTC) monograph drug products for the t...
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FDA Roundup: November 1, 2024Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA published the FDA Voices: “FDA Takes Exciting Steps Toward Establishin...
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FDA Roundup: October 29, 2024Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA responded to objections on the agency’s final rule that removed the au...
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FDA Roundup: October 25, 2024Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA updated the advisory for the outbreak of E. coli O157:H7. A specific i...
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$76 Million in Illegal E-Cigarettes Seized in Joint Federal OperationToday, the U.S. Food and Drug Administration, in collaboration with U.S. Customs and Border Protection (CBP), announced the administrative seizure of approximately three million units of unauthorized...