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Mandated label changes?

This article was originally published in The Tan Sheet

Executive Summary

"For me, the FDA has to be given the ability to mandate labeling changes after approval," GlaxoSmithKline Senior VP-Worldwide Development Ronald Krall stated at the meeting. "After appropriate consultation, including experts in the field and the company, FDA needs to be able to say 'enough is enough, here's the labeling.' We don't need this because FDA needs a hammer, but because the public is uncomfortable with how long it takes us to communicate information about our products"...





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