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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.

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FDA Received More User-Fee Paying Applications In FY 2004 Than Expected

With a “greater than anticipated” number of fee-paying applications received by FDA, the agency collected $5 mil. more than projected at the beginning of the year, the FY 2004 PDUFA Financial Report states.

FDA Received More User-Fee Paying Applications In FY 2004 Than Expected

With a “greater than anticipated” number of fee-paying applications received by FDA, the agency collected $5 mil. more than projected at the beginning of the year, the FY 2004 PDUFA Financial Report states.

FDA Has 18 Applications Remaining With User Fee Dates In 2004

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