Appendix C: Completion of PDUFA III Goals Not Part of PDUFA IV
PDUFA III Management Initiatives Performance – Reviewable Unit Letter Notification
Goal: Issue Discipline Review Letters for Pre-submitted “Reviewable Units” of NDAs and BLAs
The table below summarizes the annual review time and performance goals for reviewable unit letter notifications for NDAs and BLAs.
|Reviewable Unit Type||Review Time Goal||Performance Goal|
|FY 04||FY 05||FY 06||FY 07||FY 08|
|NDA||6 months||30%||50%||70%||90%||No Goal|
There were no reviewable unit submissions for a PDUFA goal in FY 2008 (see corresponding graph and table).
|Reviewable Unit Submissions|
|Type||FY 04||FY 05||FY 06||FY 07||FY 08|
FY 2007 Submissions
FDA reviewed on time most (5 of 8) pre-submitted reviewable units of NDAs and BLAs submitted in FY 2007 but did not meet the performance goal (see table below). This goal does not continue beyond FY 2007.
|Reviewable Unit Type||Performance Goal||Received||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|
|NDAs and BLAs||Act On 90 Percent Within 6 months||8||3||0||100%||5||3||63%|