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911 articles found
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FDA Takes Action to Restrict Unlawful Import of XylazineToday, the U.S. Food and Drug Administration announced that it has taken action to restrict the unlawful entry of xylazine active pharmaceutical ingredients and finished dosage form drug products into... -
FDA Roundup: February 28, 2023Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA is withdrawing the 2005 proposed rule, “Food Standards; General Principl...
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FDA Outlines Steps to Strengthen Tobacco ProgramToday, the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) outlined the steps it plans to take in response to an external evaluation I commissioned last year from an independent...
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FDA Roundup: February 24, 2023Today, 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: “The Work of FDA Continues in Thousands of Wor...
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FDA Files Civil Money Penalty Complaints Against Four E-Cigarette Product ManufacturersToday, the U.S. Food and Drug Administration announced it has filed civil money penalty (CMP) complaints against four tobacco product manufacturers for manufacturing and selling e-liquids without mark...
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FDA Provides Draft Labeling Recommendations for Plant-based Milk Alternatives to Inform ConsumersToday, the U.S. Food and Drug Administration announced draft recommendations for industry on the naming of plant-based foods that are marketed and sold as alternatives to milk. The draft guidance also...
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FDA Roundup: February 17, 2023Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA approved Lamzede (velmanase alfa) the first enzyme replacement the...
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Use of Fast Healthcare Interoperability Resources (FHIR) in the Generation of Real World Evidence (RWE)Regina Zopf, FDA, Bethesda, MD, USA Jeff Abolafia, Rho, Chapel Hill, NC, USA Bhargava Reddy, UCB, Raleigh, NC USA ABSTRACT There is a lot of interest in the clinical trial community to understand wha...
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La FDA lleva a cabo actividades adicionales para prevenir las sobredosis de drogas y reducir los fallecimientosAbordar la crisis de sobredosis de drogas y el trastorno por consumo de sustancias (SUD, por sus siglas en inglés) es un tema de gran preocupación para nuestra nación y sigue siendo una prioridad de s...
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FDA Advances Additional Activities to Prevent Drug Overdoses and Reduce DeathAddressing the drug overdose crisis and substance use disorder (SUD) is an issue of great concern for our nation and remains a top public health priority for the U.S. Food and Drug Administration. Upo...