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Year-End 2004 Submissions Slow; FDA Returns To Boom In Approvals

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Year-end submissions are down, but end-of-year approvals are up at 15 versus six in 2003. December 2004 saw 14 filings compared to 17 a year ago. Submission slow-down reflects diminishing late-stage pipelines across industry; only five of the end-of-year filings were for new molecular entities

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