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