About FDA
Median Approval Times PDUFA FY 2006
The vertical clustered column graph presents median approval times for priority and standard applications filed for FY 1998 through FY 2005. It is footnoted that data for FY 2004 and FY 2005 is estimated. The scale is in increments of 6 with a range from 0 to 24. It shows that the median approval time for priority applications stayed constant at 6.0 months during FY 1998 and FY 1999 with a slight increase to 6.3 months in FY 2000. In FY 2001, the median approval time for priority applications increased to 15.6 months and then decreased to 9.0 months in FY 2002 and 6.1 months in FY 2003. The median approval times for priority applications were estimated to continue to decrease to near 6.0 months in FY 2004 and FY 2005. The graph also shows that the median approval time for standard applications was 18.1 months in FY 1998, decreased to 12.0 months in FY 1999, increased to 14.3 months in FY 2000, increased to 19.9 months in FY 2001, dropped to 13 months in FY 2002, and 12.3 months in FY 2003. In FY 2004, the median approval time for standard applications was estimated to decrease to 10.5 months and estimated to increase to 13.7 months in FY 2005.







