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FDA 2002 NME approval times (correction)

Executive Summary

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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FDA Faster Approval Times For 2002 NMEs Aided By Resubmissions
FDA Faster Approval Times For 2002 NMEs Aided By Resubmissions
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