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Few, But Fast And On Time: 2010 Saw Low NMEs, But Almost All Were First-Cycle Approvals And FDA Met Most User Fees

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

The rate of first-cycle approvals of new molecular entities in 2010 eclipsed previous highs, suggesting that the regulatory innovations of the FDA Amendments Act are paying off in terms of review efficiency.

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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.

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

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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