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911 articles found
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FDA Urges Companies to be ’Recall Ready’ to Protect Public Health as Part of Final Guidance for Voluntary RecallsToday, the U.S. Food and Drug Administration finalized guidance to help companies prepare to quickly and effectively remove violative products from the market. The guidance describes steps companies s... -
FDA Clinical Trial Guidances Share Biden Administration’s Goals for Advancing Development of Cancer TreatmentsToday, the U.S. Food and Drug Administration issued three final guidances to industry regarding cancer clinical trials that parallel the goals of President Biden’s recently announced effort to renew a...
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FDA Roundup: February 25, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:On Feb. 24, the FDA issued an update on our continuing efforts to understand and reduce...
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Making Sense of the Various ADaM DocumentsIntroduction This article was written to explain why there are so many Analysis Data Model (ADaM) documents and to help the ADaM user see how they have been designed to work together. History The...
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FDA Approves Treatment for Wider Range of Patients with Heart FailureToday, the U.S. Food and Drug Administration approved Jardiance (empagliflozin) to reduce the risk of cardiovascular death and hospitalization for heart failure in adults.Jardiance was originally appr...
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FDA Permits Marketing of First Condom Specifically Indicated for Anal IntercourseToday, the U.S. Food and Drug Administration authorized the marketing of the first condoms specifically indicated to help reduce transmission of sexually transmitted infections (STIs) during anal inte...
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FDA Roundup: February 22, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:Today, the FDA posted a new resource, At-Home COVID-19 Diagnostic Tests, that provides a...
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FDA Roundup: February 18, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:Today, the FDA is announcing that it has found an additional four lots of AstraZeneca CO...
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FDA Roundup: February 11, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:On Feb. 11, the U.S. Food and Drug Administration (FDA) opened the application portal fo...
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Coronavirus (COVID-19) Update: FDA Authorizes New Monoclonal Antibody for Treatment of COVID-19 that Retains Activity Against Omicron VariantToday, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for a new monoclonal antibody for the treatment of COVID-19 that retains activity against the omicron variant....