Report on FY 2008 PDUFA Procedural and Processing Goals, Initiatives, And Commitments

FY 2008 PDUFA Performance Report Table of Contents

This section presents FDA’s performance in achieving the FY 2008 procedural and processing goals and accomplishments for PDUFA IV initiatives and commitments. The following information refers to FDA performance presented in this section. Unless otherwise noted, performance data is reported as of September 30, 2008.

• The procedural and processing goals reflect performance related to the Investigational New Drug Application (IND) phase of drug development. The procedural and processing goals FDA committed to achieve were designed to improve application submissions and FDA-sponsor interactions during new drug development and application review.
• The management initiatives under PDUFA IV relate to improving the overall application review process.
• The electronic applications and submissions commitments relate to the Information Technology (IT) initiatives and activities of PDUFA IV.

A detailed description of the goals, commitments, the annual performance targets, and definitions of terms can be found in Appendix A.

Next page: Performance At-A-Glance for FY 2008