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FDA Faster Approval Times For 2002 NMEs Aided By Resubmissions

Executive Summary

The average total approval time for new molecular entities cleared by FDA in 2002 was 15.2 months, an analysis of new drug approvals shows

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FDA 2002 NME approval times (correction)

FDA's average approval time for new molecular entities approved in 2002 is 17 months. "The Pink Sheet" (1Jan. 6, p. 10) incorrectly reported that Alliance Pharmaceuticals' Imagent NDA had been resubmitted and therefore miscalculated the approval time average. Imagent (perflexane) was approved in 31.6 months...

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