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278 articles found
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FDA Clears First Blood Test Used in Diagnosing Alzheimer’s DiseaseThe U.S. Food and Drug Administration today cleared for marketing the first in vitro diagnostic device that tests blood to aid in diagnosing Alzheimer’s disease. The Lumipulse G pTau217/ß-Amyloid 1-42... -
FDA to Host Inaugural, Independent, Scientific Expert Panel Open to PublicAs part of the Trump Administration’s commitment to transform American health care and rebuild trust in public health, the U.S. Food and Drug Administration’s Commissioner Martin A. Makary, M.D., M.P....
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FDA Begins Action To Remove Ingestible Fluoride Prescription Drug Products for Children from the MarketThe U.S. Food and Drug Administration (FDA) today announced that it is initiating action to remove concentrated ingestible fluoride prescription drug products for children from the market. Unlike toot...
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HHS, FDA Issue RFI on Deregulatory Plan to Lower Costs and Empower ProvidersThe U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) today announced the launch of a public Request for Information (RFI) to identify and eliminate ou...
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HHS, FDA Initiate Comprehensive Review of Nutrients in Infant FormulaThe U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) today announced the next steps in Operation Stork Speed--a groundbreaking initiative to ensure the sa...
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FDA Approves Three Food Colors from Natural SourcesThe U.S. Food and Drug Administration today announced it granted three new color additive petitions that will expand the palette of available colors from natural sources for manufacturers to safely us...
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FDA Announces Completion of First AI-Assisted Scientific Review Pilot and Aggressive Agency-Wide AI Rollout TimelineIn a historic first for the agency, FDA Commissioner Martin A. Makary, M.D., M.P.H., today announced an aggressive timeline to scale use of artificial intelligence (AI) internally across all FDA cente...
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FDA Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing FacilitiesToday, the U.S. Food and Drug Administration announced its intent to expand the use of unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines, and other me...
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HHS, FDA to Phase Out Petroleum-Based Synthetic Dyes in Nation’s Food SupplyThe U.S. Department of Health and Human Services and U.S. Food and Drug Administration (FDA) today announced a series of new measures to phase out all petroleum-based synthetic dyes from the nation’s...
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FDA Commissioner Makary Announces New Policy on Individuals Serving on FDA Advisory CommitteesIn keeping with U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr.’s promise to carry out the Department’s work with “radical transparency” and mitigate perceived industry in...