Percent of Filed NDAs and BLAs Approved on First Review Cycle PDUFA FY 2007
The vertical clustered column graph presents the percent of filed priority and standard NDAs and BLAs approved on the first review cycle for FY 1997 through FY 2006. NDAs and BLAs are shown as a combined number. The scale is increments of 20 with a range from 0 to 100 percent. The graph shows that the percentages of priority applications approved on the first cycle was 46 percent in FY 1997, increased to 50 percent in FY 1998, increased again to 58 percent in FY 1999, decreased to 45 percent in FY 2000, and decreased again to 15 percent in FY 2001. From FY 2002 through FY 2006, the percentage of priority applications approved on the first cycle increased each year with 47 percent in FY 2002, 52 percent in FY 2003, 59 percent in FY 2004, 60 percent in FY 2005, and 66 percent in FY 2006. The graph also shows the percentages of standard applications approved on the first cycle that began at 45 percent in FY 1997, decreased to 29 percent in FY 1998, increased to 40 percent in FY 1999, decreased to 31 percent in FY 2000 and decreased again to 20 percent in FY 2001. The percentages of standard applications approved on the first cycle increased to 36 percent for FY 2002 and FY 2003, increased again to 50 percent for FY 2004, decreased to 38 percent in FY 2005, and increased to 46 percent in FY 2006.