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Percent of Filed NDAs and BLAs Approved on First Review Cycle PDUFA FY 2006
The vertical clustered column graph presents the percent of filed NDAs and BLAs approved on the first review cycle for FY 1998 through FY 2005. The scale is increments of 10 with a range from 0 to 60 percent. It shows that the percentage of priority applications approved on the first cycle was 50 percent in FY 1998, increased to 58 percent in FY 1999, and then dropped to 45 percent in FY 2000. In FY 2001, the percentage of priority applications approved on the first cycle dropped to 15 percent and then increased in FY 2002 to 47 percent. The percentages of priority applications approved on the first cycle continued to fluctuate with an increase in FY 2003 to 52 percent and a slight increase to 55 percent in FY 2004 and a slight decrease to 54 percent in FY 2005. The graph also shows the percentages of standard applications approved on the first cycle fluctuated from 29 percent in FY 1998, to 39 percent in FY 1999, and then to 31 percent in FY 2000. In FY 2001, the percentage of standard applications approved on the first cycle dropped to 19 percent, increased to 36 percent in FY 2002, stabilized at 36 percent in FY 2003, increased to 44 percent in FY 2005 and fell to 29 percent in FY 2005, the same level as in FY 1998.
