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Off-Label Drug-Eluting Stent Data Weak; Label Should Be Revised – Panel

This article was originally published in The Gray Sheet

Executive Summary

FDA panel members recommended changes to drug-eluting stent labeling that would more clearly indicate differences between on- and off-label use. However, they found that the data was insufficient to make definitive conclusions about risks for unapproved applications, which account for the majority of stent placements
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