About FDA
PDUFA FY 2004 Median Approval Times
The median approval time for NDA and BLA original priority applications was 12.2 months and 21.6 months for standard applications in FY 1994. The median approval time for priority applications dropped to 11.8 months and 15.8 months for standard applications in FY 1995. The median approval time for priority applications dropped again to 8.2 months and 14.7 months for standard applications in FY 1996. The median approval time for priority applications dropped yet again to 7.8 months and 12.5 months for standard applications in FY 1997. The median approval time for priority applications experienced another drop to 6.0 months and an increase of 17.9 months for standard applications in FY 1998. The median approval time for priority applications remained at 6.0 months and dropped to 12.0 months for standard applications in FY 1999. The median approval time for priority applications remained again at 6.0 months and increased to 13.9 months for standard applications in FY 2000. The median approval time for priority applications significantly increased to 15.6 months and 22.1 months for standard applications in FY 2001. The median approval time for priority applications significantly dropped to 9.0 months and 12.8 months for standard applications in FY 2002. The median approval time for priority applications is estimated to drop again to 6.4 months and estimated to increase to 13.8 months for standard applications for FY 2003.
