RE-LY Study Oversight Weaknesses A Factor In Pradaxa “Refuse-To-File” Action
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Weaknesses in the oversight of the Pradaxa pivotal study by Boehringer Ingelheim GmbH and its contract research organization may have led to data quality problems that ultimately delayed FDA approval of the anticoagulant by four months.
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Oncology drug sponsors who seek FDA accelerated approval based upon single-arm studies run the risk of a “refuse-to-file” letter, a new analysis suggests.