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