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Expedited Approval Pathways Associated With Increased Safety-Related Label Changes, Study Finds By Zachary Brennan - Published 08 September 2017

The US Food and Drug Administration (FDA) is increasingly granting faster reviews via expedited regulatory pathways, but a new article published in the British Medical Journal found an association between these expedited pathways and the likelihood of safety-related labeling changes.

Categories: News, US, FDA

Tags: breakthrough drug, accelerated approval, fast track, drug safety, label changes