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911 articles found
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FDA In Brief: FDA Issues Procedural Notice on Potential Plans to Conduct Research About Use of ‘Healthy’ Symbols on Food ProductsThe following quote is attributed to Conrad Choiniere, Ph.D., director of the Office of Analytics and Outreach, Center for Food Safety and Applied Nutrition "The FDA understands that consum... -
Coronavirus (COVID-19) Update: FDA Outlines Inspection and Assessment Activities During Pandemic, Roadmap for Future State of OperationsToday, the U.S. Food and Drug Administration issued a new report titled, “Resiliency Roadmap for FDA Inspectional Oversight,” outlining the agency’s inspectional activities during the COVID-19 pandemi...
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Coronavirus (COVID-19) Update: May 4, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:The FDA Center for Drug Evaluation and Research (CDER) continu...
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Coronavirus (COVID-19) Update: April 30, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:On April 28, the FDA approved an abbreviated new drug applicat...
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FDA Approves Treatment for Chronic Kidney DiseaseToday, the U.S. Food and Drug Administration approved Farxiga (dapagliflozin) oral tablets to reduce the risk of kidney function decline, kidney failure, cardiovascular death and hospitalization for h...
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FDA Approves Higher Dosage of Naloxone Nasal Spray to Treat Opioid OverdoseThe U.S. Food and Drug Administration announced today the approval of a higher dose naloxone hydrochloride nasal spray product to treat opioid overdose. The newly approved product delivers 8 milligram...
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FDA Commits to Evidence-Based Actions Aimed at Saving Lives and Preventing Future Generations of SmokersToday, the U.S. Food and Drug Administration announced it is committing to advancing two tobacco product standards to significantly reduce disease and death from using combusted tobacco products, the...
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La FDA se compromete a tomar medidas basadas en la evidencia dirigidas a salvar vidas y prevenir futuras generaciones de fumadoresHoy, la Administración de Alimentos y Medicamentos de los EE.UU. (FDA, por sus siglas en inglés) anunció que se compromete a avanzar en el desarrollo de dos normas para productos del tabaco y reducir...
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FDA Takes Action For Failure to Submit Required Clinical Trial Results Information to ClinicalTrials.GovBeing transparent about the results of completed clinical trials enables important advances in the development of medical products and helps ensure a safe, effective and efficient clinical research en...
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Coronavirus (COVID-19) Update: April 27, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:As part of the FDA’s effort to protect consumers, the agency i...