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911 articles found
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FDA to Issue New Commissioner’s National Priority Vouchers to Companies Supporting U.S. National InterestsThe U.S. Food and Drug Administration today announced its Commissioner’s National Priority Voucher (CNPV) program to enhance the health interests of Americans. The new voucher may be redeemed by drug... -
FDA Launches Agency-Wide AI Tool to Optimize Performance for the American PeopleThe U.S. Food and Drug Administration (FDA) today launched Elsa, a generative Artificial Intelligence (AI) tool designed to help employees—from scientific reviewers to investigators—work more efficien...
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FDA Takes Action to Address Data Integrity Concerns with Two Chinese Third-Party Testing FirmsThe U.S. Food and Drug Administration (FDA)’s Center for Devices and Radiological Health (CDRH) issued General Correspondence Letters to two third-party testing companies in China after discovering da...
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FDA and CBP Seize Nearly $34 Million Worth of Illegal E-Cigarettes During Joint OperationThe U.S. Food and Drug Administration (FDA) today announced the seizure of nearly two million units of unauthorized e-cigarette products in Chicago, with an estimated retail value of $33.8 million. Th...
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FDA takes steps to enhance state importation programs to help lower prescription drug pricesThe U.S. Food and Drug Administration is continuing to take steps to help state importation programs provide safe, effective and more affordable drugs for American patients, as part of its efforts to...
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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...
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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 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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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...