Executive Summary

This report updates the Agency's review performance on the FY 2003 application submissions and presents preliminary performance in reviewing FY 2004 application submissions and meeting other PDUFA performance goals.

With all but two of the original applications submitted during FY 2003 having been reviewed and acted on by September 30, 2004, FDA can report that it exceeded all the review performance goals for FY 2003.

FDA's PDUFA workload increased substantially in FY 2004. This included an increase in review workload, such as applications, supplements, and resubmissions, as well as an increase in administrative workload, such as responding to meeting management activities and other review processes such as special protocol assessments.

FDA received a total of 137 original NDAs and BLAs in FY 2004. This represented a 5-year high and an increase of 26 percent over FY 2003.
FDA received 81 resubmitted NDAs and BLAs in FY 2004. This represented the first increase in this category in 5 years.
The increased number of submissions and resubmissions in FY 2004 translated into a 20 percent overall increased workload for meeting management goals. The Agency received 2,287 meeting requests, scheduled 2,132 meetings, and prepared meeting minutes for 1,863 meetings during FY 2004.

Although only a preliminary performance assessment on applications submitted during FY 2004 is possible now, the Agency appears to be exceeding all the review performance goals for FY 2004 submissions. Even with an increased workload when compared to FY 2003, FDA improved its level of performance on two of the three meeting management goals. And, it met or exceeded two of the remaining three FY 2004 procedural and processing goals related to clinical holds, major dispute resolution, and special protocol question assessment and agreement.

FY 2004 was also the first year for the performance goal of issuing a discipline review letter to pre-submitted "reviewable units" of NDAs/BLAs under the Continuous Marketing Applications Pilot 1 study. It was the second year for the goal of notifying sponsors of substantive deficiencies (or the lack of same) in original NDAs, BLAs, and efficacy supplements identified during the initial filing review, within 14 days after the 60-day filing date. Although it is too early to make a final determination, performance is well over the targeted performance level for both goals for FY 2004.

FDA continued its progress on PDUFA III Management Initiatives and Electronic Applications and Submissions commitments to help improve the overall review process.

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