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FDA Sets A Fast Pace Of Novel Approvals In First Half, But That's Likely To Slow

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

A sparsely populated user fee calendar for the remainder of 2011 likely precludes a repeat of FDA’s stunning approval performance in the first half of this year. Still, with 20 approvals of new molecular entities and novel biologics during those first six months, the agency is all but assured of one of its best years in a decade – at the least.
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