EMA Assessing If Kidney Injury In COVID-19 Patients Is Linked To Remdesivir
While an EU panel is examining reports of acute kidney injury in some COVID-19 patients taking remdesivir, researchers conducting a UK-based study are preparing to update their systematic benefit-risk analysis of the drug as and when more safety data becomes available.
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As companies undergo pharmacovigilance inspections from a growing multitude of regulatory authorities from around the globe, a senior pharmaceutical industry executive discusses how her company has been handling this complex and challenging task.
While inspection interviews can be stressful for drug firms, a Dutch pharmacovigilance inspector reassures companies that any responses made during the process cannot undo any good work they have already done. And they can also correct any wrong answers later on.