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Report on FY 2003 and 2004 PDUFA Goals

This report updates the Agency's review performance on the FY 2003 application submissions and evaluates its performance in reviewing FY 2004 application submissions and meeting other PDUFA performance goals.   The following information refers to FDA performance presented in this report.

• FDA has reviewed and acted on all but two of the original applications submitted during FY 2003, and final performance can now be compared against the goals and reported.
• Only a preliminary performance assessment on applications submitted during FY 2004 is possible now.   For submission categories with a 10-month review goal, it is too early to measure review performance.   For those submission categories with a review goal that is shorter than 10 months, performance on submissions received early in the fiscal year provides an early indicator of final review performance.
• FDA completed a Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) product consolidation on October 1, 2003. The product consolidation was conducted to achieve a more efficient, effective, and consistent review program for human drugs and biologics.  As a result of this change, workloads between CBER and CDER have shifted and are not comparable to previous years.   In addition, the previous association of BLA reviews only with CBER is no longer valid.   BLAs are now received by both CBER and CDER.
• The following terminology is used throughout this document: "application" means new, original application; "supplement" means supplement to an approved application; "resubmission" means resubmitted application or supplement; and "new molecular entity" or "NME" refers only to NMEs that are NDAs.   (For FDAMA purposes, all BLAs are equivalent to NMEs; however, workload and performance statistics for BLAs are reported separately.)
• The counts of NMEs in workload tables are of 'discrete,' filed NMEs.   FDA often receives multiple submissions for the same NME, for different dosage forms for example.   All are initially designated as NMEs, but, when the FDA approves the first of the multiple submissions, the Agency redesignates the others as non-NMEs.  
• Unless otherwise noted, all performance data are as of September 30, 2004.

Original Applications

Goal - Review and act on complete original NDAs and BLAs

The table below summarizes the review time goals for original NDAs and BLAs.   Over the five-year period defined by PDUFA III, the goal of reviewing 90 percent of priority applications in 6 months and standard applications in 10 months remains constant.

Workload

The number of original applications filed increased by 26 percent in FY 2004 when compared to FY 2003 and was at a five-year high.   Most of the increase was with NDAs.   The number of NME applications filed increased by 20 percent.

Original Applications Filed (Priority / Standard) Table

Original Applications

Performance

FY 2003 Submissions

FDA reviewed and acted on all 23 priority applications within 6 months, exceeding the 90 percent on-time PDUFA review goal.   FDA reviewed and acted on all but two (84 of 86) standard applications within 10 months.   With the remaining two standard applications pending and not overdue as of September 30, 2004, FDA will also exceed the on-time PDUFA review goal for standard applications.³

FY 2003 Submissions Table

FY 2004 Submissions

As of September 30, 2004, 44 percent (11 of 25) of the priority applications received in FY 2004 had been reviewed and acted on; and all had met the 6-month review goal.   Twenty percent (22 of 112) of the standard applications received had been reviewed and acted on, and all had met the 10-month review goal. With submissions still pending and not overdue, it is too early to make a final performance determination.

FY 2004 Submissions Table

Resubmitted Applications

Goal - Review and act on resubmitted NDAs and BLAs

A resubmission is a firm's response after an FDA action of "approvable", "not approvable," or "complete response" on an application.   The applicable performance goal for a resubmission is determined by the year in which the resubmission itself is received, rather than the year in which the original application was submitted.   The definitions of Class 1 and Class 2 resubmissions can be found in Appendix A. Over the 5-year period defined by PDUFA III, the goal of reviewing 90 percent of Class 1 resubmitted new applications in 2 months and Class 2 resubmitted new applications in 6 months remains constant.

Workload

The total number of resubmitted NDAs and BLAs received increased for the first time in five years in FY 2004.   The total increase was a result of a 27 percent increase in resubmitted NDAs in FY 2004. BLA resubmissions decreased substantially.

Resubmitted Applications (Class 1 / Class 2) Table

Resubmitted Applications

Performance

FY 2003 Resubmissions

FDA reviewed and acted on 24 of 25 Class 1 resubmissions within 2 months. Additionally, FDA reviewed and acted on all 49 Class 2 resubmissions within 6 months.   The PDUFA review time goal of 90 percent was exceeded in both classes of resubmissions.

FY 2003 Submissions Table

FY 2004 Resubmissions

As of September 30, 2004, 84 percent (21 of 25) of the Class 1 resubmissions received in FY 2004 had been reviewed and acted on; and all had met the 2-month review goal.   Sixty-one percent (34 of 56) of the Class 2 resubmissions had been reviewed and acted on, and all had met the 6-month review goal.   With resubmissions still pending and not overdue, it is too early to make a final performance determination.

FY 2004 Submissions Table

Efficacy Supplements

Goal - Review and act on complete efficacy supplements to NDAs and BLAs

The table below presents the annual review time goals for original efficacy supplements to NDAs and BLAs. Under PDUFA III, the goals remain steady for both reviewing 90 percent of priority supplements within 6 months and for reviewing 90 percent of standard supplements within 10 months.

Workload

The total number of efficacy supplements filed increased by 20 percent from FY 2003 to FY 2004, reversing a four-year trend downward.   This increase occurred due to increases in the numbers of supplements to both NDAs and BLAs.

Efficacy Supplements Filed (Priority / Standard) Table

Efficacy Supplements

Performance

FY 2003 Submissions

FDA reviewed and acted on all 37 priority efficacy supplements within 6 months.   FDA reviewed and acted on 97 percent (113 of 116) of the standard efficacy supplements within 10 months.   Review performance on both priority and standard efficacy supplements exceeded the 90 percent on-time PDUFA review goals.

FY 2003 Submissions Table

FY 2004 Submissions

As of September 30, 2004, 70 percent (28 of 40) of the priority efficacy supplements submitted in FY 2004 have been reviewed and acted on; and all have met the 6-month review goal.   Twenty-two percent (31 of 144) of the standard efficacy supplements have been reviewed and acted on, and all have met the 10-month review goal.   With submissions still pending and not overdue, it is too early to make a final performance determination.

FY 2004 Submissions Table

Resubmitted Efficacy Supplements

Goal - Review and act on resubmitted efficacy supplements to NDAs and BLAs

This goal is new under PDUFA III starting with FY 2003.   For Class 1 resubmissions, the goal progresses from reviewing 90 percent of FY 2004 resubmissions in 4 months and 50 percent in 2 months to reviewing 90 percent of FY 2007 resubmissions in 2 months.   For Class 2 resubmissions, the goal of reviewing 90 percent in 6 months remains constant over the five-year period.

Workload

The total number of resubmitted efficacy supplements received was relatively stable in FY 2003 and FY 2004.   Approximately 95 percent of the resubmitted efficacy supplements were to NDAs.   The number of Class 1 resubmitted supplements received doubled from FY 2003 to FY 2004.

Resubmitted Efficacy Supplements (Class 1 / Class 2) Table

Resubmitted Efficacy Supplements

Performance

FY 2003 Resubmissions

FDA reviewed and acted on 94 percent (16 of 17) of Class 1 efficacy supplement resubmissions within 2 months and all 17 within 6 months. FDA reviewed and acted on all 42 Class 2 efficacy supplement resubmissions within 6 months. Review performance on both classes of efficacy supplement resubmissions exceeded the respective PDUFA review goals.

FY 2003 Submissions Table

FY 2004 Resubmissions

As of September 30, 2004, 97 percent (34 of 35) of the Class 1 efficacy supplement resubmissions received in FY 2004 had been reviewed and acted on; and 91 percent had met the 2-month review goal and all had met the 4-month review goal.   Fifty-five percent (12 of 22) of the Class 2 resubmissions had been reviewed and acted on, and all had met the 6-month review goal.   With resubmissions still pending and not overdue, it is too early to make a final performance determination.

FY 2004 Submissions Table

FY 2004 Performance Report | Previous | FY 2003 and 2004 Goals continued

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