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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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Settling In To The “New Normal”: Midway Through 2012, Another Banner Year For Drug Approvals Is Within Reach

The forecast for 2012 approvals looks sunny. FDA approved almost as many novel drugs in the first half of 2012 as it did in the first half of its record-breaking 2011 – and the agency has more than twice as many pending NME applications with user fee goals in the next six months as it had last year.

Innovation Pays: Priority Drugs Drove Novel 2011 Approvals To New Heights

The new molecular entity and novel biologic class of 2011 isn’t just the largest since 2004 – CDER also posted near-perfect on-time review performance while maintaining healthy rates of first-cycle approvals and a low 15 month average time to approval, thanks to a high level of innovation in the novel product candidates.

Innovation Pays: Priority Drugs Drove Novel 2011 Approvals To New Heights

The new molecular entity and novel biologic class of 2011 isn’t just the largest since 2004 – CDER also posted near-perfect on-time review performance while maintaining healthy rates of first-cycle approvals and a low 15 month average time to approval, thanks to a high level of innovation in the novel product candidates.

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