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U.S. Department of Health and Human Services

About FDA

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PDUFA FY 2004 First Cycle Filings

The total number of first cycle filings was 233 in FY 2003 representing 104 NDAs, 8 BLAs, and 121 efficacy supplements. The total number of first cycle filings significantly increased to 267 in FY 2004 representing 130 NDAs, 7 BLAs, and 130 efficacy supplements.

 

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