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FDA’s Rollover Reviews: Missed Deadlines Could Inflate 2009 Approval Tally

Executive Summary

FDA is heading into 2009 with at least a dozen missed review deadlines held over from 2008 - potentially setting up the agency and industry for what could be an unusually higher number of drug and biologic approvals this year

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Second Consecutive Year Of Growth In NME Approvals In The Cards For FDA

It looks to be a good bet that 2009 will mark a second year of growth in new drug approvals: FDA entered the second half of the year with a robust first-half NME approval tally and a well-stocked pipeline of novel agents with user fee goal dates in the remaining months of the year

Second Consecutive Year Of Growth In NME Approvals In The Cards For FDA

It looks to be a good bet that 2009 will mark a second year of growth in new drug approvals as FDA enters the second half of the year with a robust first-half NME approval tally and a well-stocked pipeline of novel agents with user fee goal dates in the remaining months of the year.

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