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U.S. Department of Health and Human Services

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PDUFA FY 2000 Median Approval Time

Median total approval times have dropped from roughly 20 months for applications submitted at the start of PDUFA (FY 93) to 11.6 months (projected) for FY 99 submissions. Over the same period, median approval times for priority applications have dropped from 13 months to 6 months.

 

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