Goal: Review and Act on Original NDAs and BLAs
The table below summarizes the annual review time and performance goals for original NDAs and BLAs.
|Original Application Type||Review Time Goal||Performance Goal
FY 2008 – FY 2012 Submissions
|Priority||6 months||90% on time|
The total number of original applications (PDUFA Total) has increased two of the past 3 years and in FY 2008 reached the highest level in the past 5 years. Most of the increase was with standard applications filed which have now increased for three straight years. The number of BLAs filed increased for the third straight year, as well (see corresponding graph and table).
Original Applications Filed
|Type||FY 04||FY 05||FY 06||FY 07*||FY 08|
* FY 2007 counts were updated to reflect corrections to the FY 2007 PDUFA Performance Report.
† FDA often receives multiple submissions for the same NME, which are all initially designated as NMEs. When FDA approves the first of the multiple submissions, the others are redesignated as non-NMEs.
FY 2007 Submissions
FDA reviewed on time almost all (28 of 30) priority applications and most (83 of 93) standard applications that were filed in FY 2007 (see table below). FDA exceeded the performance goals for priority applications, but did not meet the performance goals for standard applications.
|Original Application Type||Performance Goal||Filed||Preliminary Performance as of September 30, 2007||Final Performance as of September 30, 2008|
|On Time||Overdue||Percent On Time||On Time||Overdue||Percent On Time|
|Priority||All||Act on 90 percent within 6 months||30||14||0||100%||28||2||93%|
|NMEs & BLAs||16||9||0||100%||15||1||94%|
|Standard||All||Act on 90 percent within 10 months||93||14||0||100%||83*||10||89%|
|NMEs & BLAs||28||5||0||100%||24||4||86%|
*Includes four that were pending due to amendment extensions and subsequently acted on within goal.
FY 2008 Submissions
As of September 30, 2008, performance data was available for over half (17 of 32) of priority applications filed in FY 2008, and FDA was not meeting the performance goals (see table below). With 15 priority applications pending and not overdue, including 6 NMEs and BLAs, FDA has the potential to increase performance, but not enough to meet the performance goals for priority applications. Performance data was available for less than one-fifth (20 of 111) of standard applications filed in FY 2008, and FDA was exceeding the performance goal level for standard applications. With 91 standard applications pending and not overdue, including 21 NMEs and BLAs, FDA has the potential to continue to exceed the performance goals.
|Original Application Type||Performance Goal||Filed||Performance as of
September 30, 2008
|Highest Potential Performance|
|On Time||Overdue||Percent On Time||Pending On Time||On Time||Percent On Time|
|Priority||All||Act on 90 percent within 6 months||32||12||5||71%||15||27||84%|
|NMEs & BLAs||16||6||4||60%||6||12||75%|
|Standard||All||Act on 90 percent within 10 months||111||20||0||100%||91||111||100%|
|NMEs & BLAs||32||10||1||91%||21||31||97%|
Next page: Resubmitted Applications