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New molecular entity NDAs up in FY 2004

Executive Summary

The number of new molecular entity submissions to FDA increased slightly in fiscal year 2004. FDA received 28 NME submissions in FY 2004 (ended Sept. 30), up from 25 NMEs in FY 2003 and 22 the prior year. NME submissions still have not climbed back to the level of three to five years ago. The agency received 32 NMEs in FY 2001, 30 in 2000 and 37 in 1999. BLA submissions spiked in 2004 with 20 new applications, up from eight in 2003. Nine BLAs were submitted in 2002 and eight in 2001...
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PS044906

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