FDA Roundup: September 20, 2024

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For Immediate Release: September 20, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the FDA and NIH announced “Advancing Smoking Cessation: FDA and NIH Priorities” – a joint public meeting focused on advancing innovation of smoking cessation products to help both adults and

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Anvisa publishes 1st Annual Report on Inspection Metrics in Good Clinical Practices

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A Anvisa publicou, nesta quinta-feira (19/9), o  1º Relatório Anual de Métricas de Inspeções em Boas Práticas Clínicas (BPCs)  referentes às nove inspeções realizadas em 2023 pelas equipes de inspetores na área de pesquisa clínica em medicamentos e produtos biológicos. O objetivo das inspeções é avaliar o grau de adesão dos centros, patrocinadores e profissionais envolvidos na condução de pesquisas clínicas às boas práticas clínicas.

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FDA Roundup: September 17, 2024

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For Immediate Release: September 17, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the FDA issued a draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice,” which, when finalized, will support the conduct of randomized controlled trials

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FDA Roundup: September 13, 2024

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For Immediate Release: September 13, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  On Thursday, the FDA published the FDA Voices: “Join FDA for the First National Hispanic/Latino Family Cancer Awareness Week, Sept. 20-26,” by Luckson Mathieu, MD, Senior Clinical Reviewer, DO2, OND; Donna

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SEC Charges Three Former Executives of Pharmacy Startup Medly Health Inc. with Defrauding Investors

Now-defunct digital pharmacy raised over $170 million based on fake prescriptions and fraudulently inflated revenueFor Immediate Release2024-128Washington D.C., Sept. 12, 2024 — The Securities and Exchange Commission today charged now-defunct…

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