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FDA Initiatives To Expedite Reviews Pay Off In FY’11 Approvals

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

A report released on the 35 innovative drug approvals in the fiscal year touts the role of many FDA initiatives in speeding and streamlining drug development and approval.

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FDA Wants To Help You Develop Drugs

The agency’s report on innovative drug approvals in FY 2012 documents the successful performance metrics for the 35 novel medicines, including first-cycle review rates and on-time user fee targets, but it notes that a larger problem lies in early stages of drug discovery and development – and it thinks it can help.

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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