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Inmazeb: First FDA-Approved Treatment for Ebola
Inmazeb combines three antibodies The U.S. Food and Drug Administration approved Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn), a mixture…
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Coronavirus Update for May 25, 2020
Your coronavirus update for May 25; stay up to date with Elite. More than 5.4 million cases of…
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FDA Issued Clinical Trial Guidance for COVID-19
FDA issued clinical trial guidance, though ‘Unavoidable’ protocol deviations are anticipated The U.S. Food and Drug Administration (FDA)…
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Fraudulent COVID-19 Treatment products: FDA warning
Agency reiterates no drugs or vaccines are approved for COVID-19 treatment The U.S. Food and Drug Administration (FDA)…
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FDA Informs Healthcare Professionals About Lapses in Cybersecurity
Agency clarifies no reports of breaches have occurred thus far Last week, the U.S. Food and Drug Administration…
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FDA Offers Statement on Protecting Public Interests
Postmarket drug safety surveillance practices under scrutiny In 2016, the 21st Century Cures Act (Cures Act) amended the…
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Facility Closure Leads to FDA Statement About Possible Device Shortage
Three facilities temporarily unavailable The recent closure of an ethylene oxide sterilization facility in Illinois was quickly followed…
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FDA Approves Treatment for Small Children with Rare Diseases Impacting Blood Vessels
Approval comes after wildly successful clinical trial The U.S. Food and Drug Administration recently approved Rituxan (rituximab) injection…
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FDA Clears Three Modules of Chest CT
Images can contain key information, highlight abnormalities The U.S. Food and Drug Administration (FDA) has cleared three modules…
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ACLA: “Deeply Concerned” by FDA Actions
Pharmacogenetic testing has the Association’s attention In response to the U.S. Food and Drug Administration (FDA)’s troubling actions…
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Endotracheal Tubes Recalled by Manufacturer
Potential for disconnection results in review Teleflex recalled multiple models of the Hudson RCI Sheridan and Sheridan Endotracheal…
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FDA Developing Tools for Evaluating Safety of Drugs
Peptides just one example of ongoing process FDA has seen a rapid increase in the number of new…
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