Purpose
Commissioner's Report
Overview of PDUFA Goals
Report on FY 1995 Goals
Goal 1: NDA, PLA, and ELA submissions
Goal 2: Efficacy supplements to NDAs and PLAs
Goal 3: Manufacturing supplements to NDA, PLAs and ELAs
Goal 4: Resubmitted applications for NDAs, PLAs, and ELAs
Goal 5: Recruitment of review staff
Goal 6: Project management
Goal 7: Overdue backlogs of NDAs
Goals 8 and 9: Overdue backlogs of PLAs, ELAs, and PLA/ELA supplements
Goal 10: Computer-assisted NDA standards
Discussion of FY 1995 Performance
Management Notes on Performance
Appendices:
Appendix A: PDUFA Performance Goals, FY 1993 - FY 1997
Appendix B: Approval History of FY 1993 and FY 1994 Cohorts
This report was prepared by FDA's Office of Planning and Evaluation in collaboration with the
Center for Biologics Evaluation and Research (CBER) and the
Center for Drug Evaluation and Research (CDER).
For information on obtaining additional copies contact:
Office of Planning and Evaluation (HFP-1)
Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857-0001
Phone: 301-443-4230
FAX: 301-443-3955
This report is available on the FDA Web site at http://www.fda.gov/ope/pdufa/report95.html
Section 104 of the Act requires FDA to submit two annual reports to Congress for each fiscal year during which fees are collected: 1) a performance report due within 60 days of the end of the fiscal year, and 2) a financial report due within 120 days of the end of the fiscal year. This document fulfills the first of these requirements for Fiscal Year 1995. It reports on progress toward ten FY 95 performance goals, and updates performance on the FY 94 cohort review goals.
The PDUFA goals were ambitious. FDA was asked to clear an overdue backlog equivalent to half a year of submissions, review a pending workload equal to nearly two years of submissions, and build a review capability that could meet a phased schedule of substantially accelerated review goals for applications received in the fiscal years 1994-1997.
I am pleased to announce in this Third Annual Performance Report to Congress that FDA has met or exceeded all of the PDUFA performance goals to date. FDA completely retired the overdue backlogs on schedule and surpassed all four of the measured performance goals for submissions received in FY 94.
| Performance Measure | Goal | Actual |
|---|---|---|
| Review applications for new products within 12 months | 55% | 93% |
| Review applications for new indications within 12 months | 55% | 73% |
| Review manufacturing changes within 6 months | 55% | 69% |
| Review resubmitted applications for new products within 6 months | 55% | 81% |
| Review overdue backlog pending on October 1, 1992 | 100% | 100% |
At this high performance level, FDA is more than one year ahead of schedule in meeting the escalating PDUFA goals. In the most notable performance category—for applications for new drugs and biologics—FDA is performing three years ahead of schedule.
These PDUFA performance goals focus on the timeliness of FDA review actions; they do not prescribe approval time goals. Nevertheless, quicker review should result in faster approval times. This relationship is now clearly evident. Quicker FDA reviews, along with higher quality submissions and timely resubmissions by sponsors, are significantly accelerating overall approval times.
The recent General Accounting Office (GAO) report, FDA Drug Approval: Review Time Has Decreased in Recent Years, [6] documented steadily decreasing approval times since 1987. Under PDUFA, approval times have been further reduced—resulting in even quicker patient access to safe and effective new therapies.
| 1987 | 1988 | 1989 | 1990 | 1991 | FY 93 | FY 94 |
|---|---|---|---|---|---|---|
| 29 | 27 | 23 | 23 | 21 | 17 | 17 |
The 17-month median approval times for applications received in the first two PDUFA years reflect a reduction of 23 percent in approval time compared with the two calendar years immediately preceding PDUFA. Approval times for priority applications have been even quicker—averaging only 12 months for the 22 priority applications approved under PDUFA. We are particularly pleased that GAO has found that approval times in the United States are now faster than comparable approval times in the United Kingdom.
As this report explains in greater detail, the FDA has established an exceptional record of performance in meeting the PDUFA goals thus far. Although achieving the remaining performance goals will be challenging, the commitment of FDA's dedicated employees places the agency on a confident path to successful attainment of the final FY 97 goals.
David A. Kessler, M.D.
Commissioner of Food and Drugs
These goals are not discrete objectives, but a chain of performance elements in a multi-year program to achieve a sustained capacity for high performance.
Final performance results on the annual cohorts are not fully measurable at the end of the cohort year. Several of the review performance goals specify a 12-month review period after an application's submission to the Agency. Thus, for applications submitted in late FY 95, the 12-month period for review has obviously not yet occurred. [1] Nonetheless, nearly all of the applications submitted in FY 94 have been reviewed, and therefore the timeliness of meeting the performance goals for the FY 94 cohort can now be evaluated.
In this report, discussions of the goals refer to a pre-PDUFA baseline performance statistic for the FY 90 and FY 91 cohorts of applications. This baseline, which averages the comparable Agency performance statistics for the two pre-PDUFA years, provides a convenient reference point for evaluating performance changes. The interim year, FY 92, has not been included in the baseline because some PDUFA measures extend into the last month of FY 92, and the processing of many FY 92 applications has inevitably benefited from post-PDUFA process improvements.
FY 94 cohort: Review and act upon 55 percent of complete submissions within 12 months after submission date
FY 95 cohort: Review and act upon 70 percent of complete submissions within 12 months after submission date
The rate of increase in this category of PDUFA submissions is averaging more than 17 percent per annum over the three-year period of FY 93-95.
| Number of Submissions | FY 93 [2] | FY 94 | FY 95 [3] |
|---|---|---|---|
| NDAs | 81 | 89 | 104 |
| PLAs + ELAs | 7 + 8 | 4 + 5 | 12 + 10 |
| Total | 96 | 98 | 126 |
Performance on FY 94 cohort:
As of September 30, 1995, FDA had reviewed and acted upon 93 percent of the NDAs, PLAs and ELAs submitted in FY 94 within the 12-month PDUFA timeframe. [1] FDA's on-time review performance may reach 96 percent if three of the submissions still pending are reviewed within timeframe limits. Even the 93 percent on-time review performance far exceeds the 55 percent on-time goal for the FY 94 cohort. It also exceeds the final performance goal (90 percent) set for standard applications submitted in the FY 97 cohort. From this perspective, FDA's performance on the FY 94 cohort is three years ahead of the PDUFA performance goal schedule for standard applications.
In comparison with past FDA performance, review of the FY 94 cohort decisively departs from historic trends. Examined against immediate pre-PDUFA performance in FY 90-91, the FY 94 cohort more than doubles (from 42 percent to 93 percent) the proportion of submissions that were reviewed within a 12-month timeframe after submission. It also marks a substantial improvement over the 69 percent on-time review performance realized for the FY 93 cohort. [See Figure 1]
Performance on FY 95 cohort:
As of September 30, 1995 FDA had reviewed and acted upon 5 percent of the NDAs, PLAs and ELAs submitted in FY 95 within the 12-month PDUFA timeframe. [1] The remaining 95 percent of the FY 95 cohort are pending action and are not yet overdue. Most of this cohort has considerable time remaining for review within the PDUFA timeframe because the cut-off date for inclusion in the FY 95 cohort was September 30, 1995. Next year, the FY 95 cohort will reach the point on December 31, 1996, when on-time review performance can be assessed for every submission in the cohort. The best indicator of expected performance on the FY 95 cohort is that of the FY 94 cohort. Based on year-to-year performance trends, FDA projects that the on-time review performance for the FY 95 cohort will substantially exceed the PDUFA performance standard of reviewing and acting upon 70 percent of NDA, PLA and ELA submissions within 12 months of their submission to FDA.
FY 94 cohort: Review and act upon 55 percent of submissions within 12 months after submission date
FY 95 cohort: Review and act upon 70 percent of submissions within 12 months after submission date
This category of PDUFA submissions has experienced an average annual rate of decrease close to 2 percent over the three-year period of FY 93-95.
| Number of Efficacy Supplements | FY 93 [2] | FY 94 | FY 95 [3] |
|---|---|---|---|
| NDA Supplements | 92 | 87 | 76 |
| PLA Supplements | 8 | 6 | 10 |
| Total | 100 | 93 | 86 |
Performance on FY 94 cohort:
As of September 30, 1995, FDA had reviewed and acted upon 73 percent of the efficacy supplements submitted in FY 94 within the 12-month PDUFA timeframe. [4] This 73 percent on-time review performance surpasses the 55 percent on-time goal for the FY 94 cohort. It also exceeds the performance goal (70 percent) set for efficacy supplements submitted in the FY 95 cohort. From this perspective, FDA's performance on the FY 94 cohort is one year ahead of the PDUFA performance goal schedule.
Compared with immediate pre-PDUFA performance in FY 90-91, the FY 94 cohort more than doubles (from 33 percent to 73 percent) the proportion of submissions that were reviewed within a 12-month timeframe after submission. It also shows an exceptional increase over the 41 percent on-time review performance realized for the FY 93 cohort. [See Figure 2]
Performance on FY 95 cohort:
As of September 30, 1995, FDA had reviewed and acted upon 19 percent of the NDA and PLA efficacy supplements submitted in FY 95 within the 12-month PDUFA timeframe. The remaining 81 percent of the FY 95 cohort are pending action and are not yet overdue. Most of this cohort has considerable time for review remaining within the PDUFA timeframe, because the cut-off date for inclusion in the FY 95 cohort was September 30, 1995. Next year, the FY 95 cohort will reach the point on September 30, 1996, when on-time review performance can be assessed for every submission in the cohort. The best indicator of expected performance on the FY 95 cohort is that of the FY 94 cohort. Based on year-to-year performance trends, FDA projects that the on-time performance review for the FY 95 cohort will exceed the PDUFA FY 95 cohort performance standards of reviewing and acting upon 70 percent of efficacy supplements within 12 months of their submission to FDA.
FY 94 cohort: Review and act upon 55 percent of submissions within 6 months after submission date
FY 95 cohort: Review and act upon 70 percent of submissions within 6 months after submission date
The rate of increase in this category of PDUFA submissions is averaging 9 percent per annum over the three-year period of FY 93-95.
| Number of Manufacturing Supplements | FY 93 [2] | FY 94 | FY 95 [3] |
|---|---|---|---|
| NDA Supplements | 1045 | 872 | 1253 |
| PLA, ELA Supplements | 203 | 186 | 292 |
| Total | 1248 | 1058 | 1545 |
Performance on FY 94 cohort:
As of March 31, 1995, FDA had reviewed and acted upon 69 percent of the manufacturing supplements submitted in FY 94 within the 6-month PDUFA timeframe. This 69 percent on-time review performance surpasses the 55 percent on-time goal for the FY 94 cohort, and very nearly reaches the performance goal (70 percent) set for manufacturing supplements submitted in the FY 95 cohort. From this perspective, FDA's performance on the FY 94 cohort is one year ahead of the PDUFA performance goal schedule.
The review of manufacturing supplements in the FY 94 cohort has surpassed prior performance on these supplements. Compared with immediate pre-PDUFA performance (FY 90-91), the FY 94 cohort nearly doubles (from 35 percent to 69 percent) the proportion of submissions that were reviewed within a 6-month timeframe after submission. It also shows a significant increase over the 51 percent on-time review performance achieved in the FY 93 cohort. [See Figure 3]
Performance on FY 95 cohort:
As of September 30, 1995, FDA had reviewed and acted upon 60 percent of the manufacturing supplements submitted in FY 95 within the 6-month PDUFA timeframe. An additional 33 percent are pending action and are not overdue. Based on year-to-year performance trends, FDA projects that a majority of these pending manufacturing supplements will be reviewed within the PDUFA timeframe. Next year, the FY 95 cohort will reach the point on March 31, 1996, when the on-time review performance of every submission in this cohort can be assessed. FDA expects final on-time review performance for the FY 95 cohort to exceed 80 percent. This accomplishment will set FDA's actual performance on the FY 95 cohort one year ahead of the PDUFA performance goal schedule.
FY 94 cohort: Review and act upon 55 percent of resubmissions within 6 months after submission date
FY 95 cohort: Review and act upon 70 percent of resubmissions within 6 months after submission date
The count and trend of resubmissions [5] is a definitional consequence of the distinction between pre- and post-PDUFA cohorts. Resubmissions of applications originally submitted to FDA before FY 93 are not included in the PDUFA resubmission count. Thus, the initial PDUFA years have low counts of resubmissions for inclusion in PDUFA cohorts. The resubmission cohorts in FY 96 and FY 97 are expected to be similar in size to the FY 95 cohort, although perhaps somewhat larger to reflect submission growth during the PDUFA years.
| Number of Resubmissions | FY 93 | FY 94 | FY 95 |
|---|---|---|---|
| NDA Resubmissions | 2 | 24 | 54 |
| PLA, ELA Resubmissions | 1 | 13 | 10 |
| Total | 3 | 37 | 64 |
Performance on FY 94 cohort:
As of March 31, 1995, FDA had reviewed and acted upon 81 percent of the resubmitted applications in the FY 94 cohort within the 6-month PDUFA timeframe. This 81 percent review performance surpasses the 55 percent on-time PDUFA goal for this cohort. It also surpasses the performance goal (80 percent) set for resubmissions received in the FY 96 cohort. From this perspective, FDA's performance on the FY 94 cohort is two years ahead of the PDUFA performance goal. [See Figure 4]
Performance on FY 95 cohort:
As of September 30, 1995, FDA has reviewed and acted upon 53 percent of resubmitted applications received in FY 95 within the 6-month PDUFA timeframe. An additional 44 percent are pending action and not overdue. Based on year-to-year performance trends, FDA projects that a majority of these pending resubmitted applications will be reviewed within the PDUFA timeframe. Next year, the FY 95 cohort will reach the point on March 31, 1996 when the on-time review performance of every resubmission in the FY 95 cohort can be assessed. FDA expects final on-time review performance for the FY 95 cohort to exceed 80 percent. This accomplishment will set FDA's actual on-time review performance on the FY 95 resubmission cohort one year ahead of the PDUFA performance goal schedule.
The full-implementation staffing target for PDUFA is 700 additional staff above the FY 92 base--600 review staff in CBER and CDER plus 100 positions for pre-approval inspections, information systems, fee management and other central administrative activities. For FY 95, FDA expended 453 full-time equivalent staff years of incremental effort on user fee defined activities, which constitutes 64 percent of the full increase in PDUFA effort planned for FY 97.
The calculation of incremental review effort reflects two components—the net number of new employees recruited into FDA's user fee components, and the cost allocation factor for PDUFA-defined work in each organizational unit. The Agency, in collaboration with Arthur Andersen & Company, updated these 1993 PDUFA cost allocation factors during FY 95. These updated cost allocation factors, in conjunction with the year-to-year changes in net recruiting statistics in CBER and CDER, ensure that FDA had on board before December 31, 1994 an incremental review staff sufficient to generate at least 350 full-time equivalent staff years of PDUFA-related work (50 percent of 700) by the end of FY 95.
The discipline specialization of the net 399 new user-fee employees on board at the end of FY 95 in CBER and CDER is depicted in the accompanying table. It illustrates FDA's continuing recruitment focus on highly specialized skill categories to staff the PDUFA program, as well as the formidable challenge of offsetting continuing attrition across the broader base of FDA's drug and biologic review programs. While FDA has achieved a gain of 127 employees in CBER and CDER over last year's comparable statistic, this accomplishment has required hiring more than 300 new employees during FY 95 to compensate for attrition. A comparable recruitment effort will be necessary in FY 96. Successful recruiting during the current year will be an essential prerequisite for achieving the high performance demands of the final PDUFA goals.
| New Hires | Net Additions | |
|---|---|---|
| Medical/Dental | 122 | 65 |
| Chemist | 60 | 25 |
| Consumer Safety Officer | 102 | 64 |
| Microbiologist/Biologist | 166 | 52 |
| Biostatistician | 27 | 21 |
| Pharmacologist | 40 | 25 |
| Other Scientist | 99 | 45 |
| Support | 407 | 102 |
| Total | 1023 | 399 |
Note: The recruitment of 1023 employees to achieve a net gain of 399 employees reflects attrition across the broader employee base engaged in "the process of the review of human drug applications" as defined in the statute.
By the beginning of 1995, CBER had in place an effective project management system. In the fall of 1993, CBER began operating a monthly performance tracking system as part of its Managed Review Process. The system employs project management techniques and methods and is designed specifically to track PDUFA-defined performance. Enhancements to the initial system continue to be made to give CBER the capability to address unique management needs. The system also highlights high priority categories of workload, such as AIDS and biotechnology.
The current configuration of the CBER performance tracking system is used by Center management not only to record performance monthly, but also to present a projected calendar of all future PDUFA deadlines for reviews in progress. This management forecast is sufficiently detailed to give early warning of workload bottlenecks and unusual staffing needs.
The PDUFA interim goals specify that backlogs of pre-PDUFA NDA supplements are to be eliminated within 18 months of the initiation of user fee payments, i.e., by January 2, 1995. "Backlog" is defined in the PDUFA commitments as any application that was overdue on October 1, 1992. This goal defined "eliminate the backlog" as "review and take a complete action on each of these specific overdue applications." This backlog included 60 efficacy supplements and 509 manufacturing supplements.
As of January 2, 1995 this entire PDUFA-defined backlog of NDA efficacy and manufacturing supplements was eliminated. In clearing the combined supplement backlog, FDA has approved 388 (68 percent) of the 569 overdue supplements: 24 (40 percent) of the 60 overdue efficacy supplements, and 364 (72 percent) of the 509 overdue manufacturing supplements. Of the remaining 181 submissions, sponsors withdrew 97 supplements (54 percent), many of which had been inactive for years. Currently, only 58 of these supplements are classified "not approvable" by FDA. These supplements are presently with their sponsors, who will decide whether or not to resubmit the applications with further data or analyses.
| NDA Supplement Type | Backlog as of 10/1/92 | Backlog as of 1/2/95 |
|---|---|---|
| Efficacy | 60 | 0 |
| Manufacturing | 509 | 0 |
| Total | 569 | 0 |
Goal 9: Eliminate overdue backlog of PLAs, ELAs, and PLA/ELA supplements by July 2, 1995
The PDUFA interim goals specify that backlogs of NDAs, PLAs, ELAs, and PLA/ELA supplements are to be eliminated by July 2, 1995—the date 24 months after the initiation of user fee payments. "Backlog" is defined in the PDUFA commitments as any application that was overdue on October 1, 1992. These goals defined "eliminate the backlog" as "review and take a complete action on each of these specific overdue applications." These backlogs included 34 NDAs, 8 PLAs, 14 ELAs, 6 PLA efficacy supplements and 64 ELA manufacturing supplements.
As of July 2, 1995, FDA met the goal of eliminating the PDUFA-defined backlog of 34 NDAs. In clearing the NDA backlog, FDA has approved 21 (62 percent) of the 34 NDAs. Sponsors have withdrawn 5, resubmitted 4, and currently 4 are classified as "not approvable" by FDA. These "not approvable" applications are presently with their sponsors, who will decide whether or not to resubmit the applications with further data or analyses.
FDA also met the goal of eliminating the PDUFA-defined backlog of PLAs, ELAs and PLA/ELA supplements before July 2, 1995. Most of these submissions were inactive, and 55 (60 percent) were withdrawn by their sponsors. Of the remaining 37 submissions, 22 were approved, 2 are currently classified "approvable," and 13 are classified as "not approvable."
| Submission Type | Backlog as of 10/1/92 | Backlog as of 7/2/95 |
|---|---|---|
| NDAs | 34 | 0 |
| PLAs, ELAs | 22 | 0 |
| PLA Efficacy Supplements | 6 | 0 |
| ELA Manufacturing Supplements | 64 | 0 |
| Total | 126 | 0 |
The Agency has developed uniform standards for computer-assisted review, and continued to refine these standards during FY 95. Early in the fiscal year FDA published a preferred computer-assisted NDA (CANDA) standard in a CANDA Guidance Manual. This standard states that FDA will provide hardware, software, and operational support for multi-user or networked CANDAs that meet certain specifications, which are designed to ensure that the submissions can be mounted on FDA equipment and used by FDA reviewers.
FDA and the industry are moving away from customized computer-assisted NDAs that rely on stand-alone computers, and are moving instead to more standardized electronic submissions that are placed on a network for multi-user access. When the submission is designed to use the recommended combination of hardware and software, the sponsor need only supply its NDA-specific data and the search and retrieval and computational algorithms needed to access the information. Using the Agency's own hardware and software, FDA personnel will manage the operation and maintenance of these submissions using procedures and instructions supplied by each sponsor. Alternative hardware and software is permitted if sponsors can show that the proposed configuration will perform properly in FDA's computer environment. However, such alternative configurations may require more support by the sponsor of the application, including the provision of hardware and software with the submission. Standards for electronic submissions will continue to be revised as the technology evolves.
The Comptroller General, in a recent GAO report, [6] measured the median approval time of NDA applications submitted in the five calendar years preceding the commencement date for the first PDUFA submission cohort on September 1, 1992. The report documented the declining median approval times shown in Figure 5. The median NDA approval time averaged 22.2 months for the two calendar years (1990-91) immediately preceding PDUFA. The comparable median times for the first two PDUFA years (FY93-94) are approximately 17 months. This calculation makes appropriate allowance for likely future approvals from these cohorts. [7] This savings of more than 5 months clocks the PDUFA years at a 23 percent faster pace for time of approval than the NDA cohorts in the two calendar years preceding PDUFA.
Median approval times for PLAs were not measured in the GAO report, but the median approval time of 12.2 months for the five PLAs approved from the FY 93 and FY 94 PDUFA cohorts compares favorably with the NDA median approval statistics.
The high percentage of first reviews accomplished within the 12-month PDUFA timeframe is only one reason for the quicker approval pace. Other important factors include:
High Rates of Affirmative First Actions: [8] The proportion of first actions that are approved or approvable is a key factor in timely approval statistics. For the FY 94 cohort, this measure was very positive, as the following statistics show.
| Submission Types | FY 94 Cohort |
|---|---|
| NDAs, PLAs, ELAs | 48% |
| Efficacy Supplements | 69% |
| Manufacturing Supplements | 76% |
| Resubmissions | 62% |
The proportion of affirmative first actions to the projected number of eventual approvals in any submission cohort measures the approximate percentage of approvals that will be easily—and quickly—achieved without major revisions. For example, the affirmative rate of 48 percent in NDA first actions means that more than three-fourths of the projected approvals (63 percent of the cohort) are identified quickly in the first review action. As a result, a comparatively small number of eventual approvals go through time-consuming major revisions in response to "not approvable" action by FDA.
Quick Action on Approvables: The FY 94 cohort has established a very fast pace for sponsor turn-around and Agency action on approvable applications. As the statistics and individual application histories in Appendix B illustrate, sponsors are resubmitting approvable NDA and PLA applications to the agency in an average of 1.4 months and FDA is issuing approval letters 2.7 months after resubmission.
Effective Refuse-to-File Screening: In FY 93, the new PDUFA requirement for "complete" submissions to FDA had a substantial impact on the frequency of refuse-to-file decisions by the Agency. As Figure 6 shows, this appears to have been a temporary "learning curve" experience for sponsors. Now, the FY 95 refuse-to-file frequency is less than pre-PDUFA rates of refuse-to-file. The benefit of this rigorous front-end screening of incomplete applications in FY 93 and FY 94, however, was to eliminate from these cohorts applications that were incomplete and would have otherwise gradually accumulated their submission requirements while under review. FDA's ability to control the elapsed time for review of these applications was obviously limited.
Another favorable benefit of the elevated refuse-to-file rate has been an increase in the percentage of projected approvals from the PDUFA cohorts, because about one-third of all refused applications are never resubmitted. The previously mentioned GAO report calculated ultimate approval rates for pre-PDUFA cohorts at 56 percent. The FY 93 cohort has already exceeded this rate, and the expected final approval rates for FY 93 and FY 94 will probably be in the mid-60 percent range.
| PDUFA Workload | FY 93 | FY 94 | FY 95 |
|---|---|---|---|
| NDAs, PLAs, ELAs | 96 | 98 | 126 |
| Efficacy Supplements | 100 | 93 | 86 |
| Manufacturing Supplements | 1248 | 1058 | 1545 |
| Resubmissions | 3 | 37 | 64 |
PDUFA Backlog Workload: The overdue backlog workload discussed in Goals 7 through 9 is summarized in the following table. Comparing these counts to the cohort workload above shows that the overdue backlog defined on October 1, 1992 was equivalent to about 6 months of submissions received in the FY 93 cohort year.
| NDAs, PLAs, ELAs | 56 |
|---|---|
| Efficacy Supplements | 66 |
| Manufacturing Supplements | 573 |
| Resubmissions | (included in above counts) |
Pre-PDUFA Workload: In addition to the two preceding categories of PDUFA workload, FDA had a considerable volume of pending, but not overdue, workload on October 1, 1992 that was omitted from PDUFA goals. Most of the submissions received in FY 92, as well as many resubmissions from prior years, were in this category. As the following table shows, this workload was significant in size—equivalent to about two years of original NDA/PLA submissions.
| NDAs, PLAs, ELAs | 201 |
|---|---|
| Efficacy Supplements | 58 |
| Manufacturing Supplements | 571 |
| Resubmissions | (included in above counts) |
This workload, excluded from specific PDUFA performance goals, has not been neglected. To date, more than 99 percent of these pre-PDUFA submissions have been reviewed and acted upon. Among the NDA, PLA and ELA applications in this category, more than 80 have been approved during the PDUFA years. In addition to the 839 applications fixed in this category on October 1, 1992, FDA continues to receive resubmissions of applications from pre-PDUFA cohorts that are excluded from the PDUFA performance goals, as well as new NDA and PLA applications that are excluded by definition from PDUFA goals. For these reasons, the counts and performance measurement in this report will not correspond with more comprehensive statistics on overall FDA workload and performance.