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Median Approval Times PDUFA FY 2007
The vertical clustered column graph presents median approval times for NDA and BLA priority and standard applications filed for FY 1997 through FY 2006. NDAs and BLAs are shown as a combined number. It is footnoted that data for FY 2005 and FY 2006 is estimated. The scale is in increments of 6 with a range from 0 to 24 months. The graph shows that the median approval time for priority applications was 7.8 months in FY 1997, decreased to 6.0 months in FY 1998 and FY 1999, increased to 6.3 months in FY 2000, increased again to 15.6 months in FY 2001, decreased to 9.0 months in FY 2002, decreased again to 6.1 months in FY 2003, and decreased to 6.0 months for FY 2004 through FY 2006. The median approval times for standard applications was 13.0 months in FY 1997, increased to 18.1 months for FY 1998, decreased to 12.0 months in FY 1999, increased to 14.3 months in FY 2000, increased again to 20.1 months in FY 2001, decreased to 13.0 months in FY 2002, decreased again to 12.7 months in FY 2003, decreased again to 10.0 months in FY 2004, increased to 13.0 months in FY 2005, and decreased to 10.3 months in FY 2006.
