New Molecular Entity Submissions Increase In FY 2004
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA receives 28 NME filings in fiscal year 2004, marking the third year of growth. However, NME submissions have not climbed back up to the 1999-2001 level. BLA submissions spike in 2004 with 20 filings, up from eight the year before.