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3d CardioFlow Sensor FDA 4d CardioFlow Sensor XL FDA 4d NexoCard — Line Extension FDA 6d Solvexa EMA 8d Optiva Insulin Pen EMA 10d NeuroPatch PMDA 12d Vantrix Generic CDSCO

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FDA Alert: updated boxed-warning labeling requirementsAffects 1 in-flight submission 21 Jul FDA Safety communication: labeling updates for coronary stent systemsAffects 5 in-flight submissions 19 Jul FDA Draft guidance: manufacturing site inspection readinessAffects 1 in-flight submission 17 Jul EMA Draft guidance: human factors for insulin delivery devicesAffects 1 in-flight submission 12 Jul

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