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Average Approval Time Slows As FDA Clears Greater Number Of NMEs In 2004

This article was originally published in The Pink Sheet Daily

Executive Summary

Average time to approval was 18.7 months for a new molecular entity in 2004, versus 17.1 in 2003. FDA cleared 31 NMEs in 2004, 10 more than the prior year. CDER appears to be setting a strong precedent with its first year of therapeutic biologic reviews.

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