Priority vs. Standard Filed NDAs and BLAs PDUFA FY 2006
The vertical clustered column graph presents the percent of submissions represented by priority and standard NDAs and BLAs applications filed for FY 2001 through FY 2006. The scale is in increments of 20 with a range from 0 to 100 percent. It shows that the number of priority NDA and BLA applications steadily rose from FY 2001 through FY 2005, but leveled off in FY 2006. In FY 2001 priority NDA and BLA applications represented 13 percent of NDA and BLA applications received by FDA. This percentage increased to 14 percent in FY 2002, increased to 21 percent in FY 2003, stabilized in FY 2004 to approximately the FY 2003 level, then increased in FY 2005 to 30 percent, before falling to 25 percent in FY 2006. The number of standard NDA and BLA applications submitted in FY 2001 represented 88 percent of NDA and BLA applications received by FDA. This percentage decreased to 86 percent in FY 2002, decreased to 79 percent in FY 2003, stabilized in FY 2004 to approximately the FY 2003 level, decreased in FY 2005 to 70 percent, then increased to 75 percent in FY 2006.