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FDA Has 18 Applications Remaining With User Fee Dates In 2004

This article was originally published in The Pink Sheet Daily

Executive Summary

Of the 18 total NDAs, there are six new molecular entities and one major biologic pending at FDA; the agency could surpass its 2003 NME tally if the six NMEs are approved. FDA remains behind in biologics with five approved thus far in 2004.
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