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

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

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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