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U.S. Department of Health and Human Services

About FDA

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PDUFA FY 2004 Resubmitted Efficacy Supplements

The total number of resubmitted efficacy supplements received was 59 in FY 2003 representing 56 NDAs and 3 BLAs. The total number of resubmitted efficacy supplements slightly dropped to 57 in FY 2004 representing 54 NDAs and 3 BLAs.

 

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