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FY 1995 PDUFA Performance Report

 


TABLE OF CONTENTS

Purpose

Commissioner's Report

Overview of PDUFA Goals 

Report on FY 1995 Goals

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


PURPOSE

The Prescription Drug User Fee Act of 1992 (Public Law 102-571) authorized revenues from fees paid by the pharmaceutical industry to expedite review by the Food and Drug Administration (FDA) of human drug applications. These revenues were directed by section 102(3) of this Act toward accomplishment of goals identified in the letters of September 14 and 21, 1992 from the Commissioner of Food and Drugs to the Chairman of the Energy and Commerce Committee of the House of Representatives and the Chairman of the Labor and Human Resources Committee of the Senate (as set forth at 138 Congressional Record H9099-H9100: daily edition of September 22, 1992).

 

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.

 


COMMISSIONER'S REPORT

The Food and Drug Administration's mission to protect the health and safety of the American people includes the obligation to make timely decisions on applications for permission to market new drugs and biologics. In 1992, Congress enacted the Prescription Drug User Fee Act (PDUFA) to provide appropriate resources to accelerate the review of applications, without compromising the safety and efficacy standards that the American people expect.

 

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.

 

 

Summary Performance on FY 94 Submissions and Backlog

Summary Performance on FY 94 Submissions and Backlog
Performance MeasureGoalActual
Review applications for new products within 12 months55%93%
Review applications for new indications within 12 months55%73%
Review manufacturing changes within 6 months55%69%
Review resubmitted applications for new products within 6 months55%81%
Review overdue backlog pending on October 1, 1992100%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.

 

Median Approval Time (Months)

Median Approval Time (Months)
19871988198919901991FY 93FY 94
29272323211717

 

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

 


OVERVIEW OF PDUFA GOALS

A set of 29 performance-based goals constitutes the management framework for PDUFA. These goals, listed by fiscal year in Appendix A, span the five-year term of the statute. Collectively, they direct management efforts toward three broad priorities: eliminating overdue backlogs, building excellence into the review process, and achieving measurable high performance.

  • Three goals relating to the elimination of overdue backlogs are scheduled for completion in FY 95.
  • Eight goals relating to the development of organizational and process excellence are distributed across all five PDUFA years, FY 93-97. They address a broad spectrum of capacity and capability enhancements ranging from recruitment and training of additional staff to electronic data handling capabilities and management control systems.
  • Eighteen goals over the last four PDUFA years set annual performance targets for the timeliness of review actions for various categories of submissions. The "interim" goals for FY 94, FY 95 and FY 96 build incrementally toward the final performance goals for FY 97.

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.

 


REPORT ON FY 1995 GOALS

Ten specific PDUFA goals relate to performance expectations in FY 95. Three goals require improvements in FDA's application review by building excellence and consistency into the review process. Seven other goals relate to measured review performance expectations for the backlog of pre-PDUFA applications and the applications received during FY 94 and FY 95 (the FY 94 and FY 95 "cohorts"). The performance goals for the annual cohorts apply to the Agency's review and issuance of a complete action letter on four categories of submissions: 1) original NDAs, PLAs, and ELAs; 2) efficacy supplements; 3) manufacturing supplements; and 4) resubmissions of original NDAs, PLAs, and ELAs that were submitted to the Agency during FY 94 and FY 95.

 

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.

 


Goal 1: Review and act upon complete NDA, PLA and ELA submissions

 

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 SubmissionsFY 93 [2]FY 94FY 95 [3]
NDAs8189104
PLAs + ELAs7 + 84 + 512 + 10
Total9698126

 

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. 

 

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.

 


Goal 2: Review and act upon efficacy supplements to NDAs and PLAs

 

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 SupplementsFY 93 [2]FY 94FY 95 [3]
NDA Supplements928776
PLA Supplements8610
Total1009386

 

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. 

 

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.

 


Goal 3: Review and act upon manufacturing supplements to NDAs, PLAs and ELAs

 

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 SupplementsFY 93 [2]FY 94FY 95 [3]
NDA Supplements10458721253
PLA, ELA Supplements203186292
Total124810581545

 

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. 

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.

 


 

Goal 4: Review and act upon resubmitted applications for NDAs, PLAs and ELAs

 

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 ResubmissionsFY 93FY 94FY 95
NDA Resubmissions22454
PLA, ELA Resubmissions11310
Total33764

 

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.

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.

 


Goal 5: Recruit and bring on board 50 percent of FDA incremental review staff by December 31, 1994

 

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.

 

User Fee Recruitment Through 9/30/95
(Since 10/1/92)

User Fee Recruitment Through 9/30/95
(Since 10/1/92)

 
New HiresNet Additions
Medical/Dental12265
Chemist6025
Consumer Safety Officer10264
Microbiologist/Biologist16652
Biostatistician2721
Pharmacologist4025
Other Scientist9945
Support407102
Total1023399

 

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.

 


Goal 6: Implement project management methodology for all PLA/ELA reviews before January 2, 1995

 

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.

 


Goal 7: Eliminate overdue backlogs of efficacy and manufacturing supplements to NDAs by January 2, 1995

 

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.

 

Backlog Eliminated: NDA Supplements

Backlog Eliminated: NDA Supplements
NDA Supplement TypeBacklog as of 10/1/92Backlog as of 1/2/95
Efficacy600
Manufacturing5090
Total5690

 


Goal 8: Eliminate overdue backlog of NDAs by July 2, 1995

 

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."

 

Backlog Eliminated: NDAs, PLAs, ELAs,
PLA and ELA Supplements 

Backlog Eliminated: NDAs, PLAs, ELAs,
PLA and ELA Supplements
Submission TypeBacklog as of 10/1/92Backlog as of 7/2/95
NDAs340
PLAs, ELAs220
PLA Efficacy Supplements60
ELA Manufacturing Supplements640
Total1260

 


Goal 10: Adopt uniform computer-assisted NDA standards during FY 95

 

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.

 


DISCUSSION OF FY 95 PERFORMANCE

The PDUFA performance goals focus on the timeliness of FDA review actions: they do not prescribe approval targets or approval time goals for any category of submission. For obvious reasons, directed outcome goals would be incompatible with FDA's regulatory responsibility and its obligation to maintain the rigor of the review process. Nevertheless, quicker reviews should result in faster approval times. The results of the first two PDUFA years produce clear evidence of this relationship.

 

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.

 

Affirmative First Actions

Affirmative First Actions
Submission TypesFY 94 Cohort
NDAs, PLAs, ELAs48%
Efficacy Supplements69%
Manufacturing Supplements76%
Resubmissions62%

 

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.

 


MANAGEMENT NOTES ON PERFORMANCE

PDUFA Cohort Workload: The overall workload statistics continue to track closely to the original projections upon which PDUFA fees and revenues were calculated in 1992. The following table summarizes submissions filed during the FY 93-FY 95 interval into the four submission categories addressed in performance goals 1 through 4.

 

PDUFA WorkloadFY 93FY 94FY 95
NDAs, PLAs, ELAs9698126
Efficacy Supplements1009386
Manufacturing Supplements124810581545
Resubmissions33764

 

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.

 

Backlog Workload as of 10/1/92

Backlog Workload as of 10/1/92
NDAs, PLAs, ELAs56
Efficacy Supplements66
Manufacturing Supplements573
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.

 

Other Pre-PDUFA Workload as of 10/1/92

Other Pre-PDUFA Workload as of 10/1/92
NDAs, PLAs, ELAs201
Efficacy Supplements58
Manufacturing Supplements571
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.

 


Footnotes

 

1.  The PDUFA program allows for one 3-month extension of the review time if there is a major amendment to an original NDA, PLA, or ELA submission in month 10, 11, or 12 of the first review cycle. A submssion that was received in late FY 94 that received such a major amendment could have as its PDUFA review goal a date in December 1995. This extension is not allowed for efficacy supplements, manufacturing supplements, or resubmissions.

 

2.  FY 93 was a 13-month fiscal year including September 1992. Calculations of annual changes in workload extrapolate counts downward to a 12-month year.

 

3.  The count of FY 95 submissions assumes that all submissions received in the last two months of FY 95 are filed. When FDA files a submission, it is deemed "complete" by PDUFA definition. FDA determines the "filability" of an application within 60 days of its original receipt. All calculations of PDUFA review times are made, however, from the original receipt date of the filed application.

 

4.  The term "supplement" applies to both drug and biologic submissions. It includes the former term of "amendments" to biologic submissions.

 

5.  A resubmission is a firm's response after an FDA action of "approvable" or "not approvable" on an application. The resubmission cohort year is defined as the year in which the resubmission itself is received, rather than its original application cohort year.

 

6.  United States General Accounting Office, FDA Drug Approval: Review Time Has Decreased in Recent Years (GAO/PEMD-96-1), October 1995. The last calendar year in the GAO report (1992) overlaps the first PDUFA year, which started on September 1, 1992, by four months. It is therefore excluded from the pre-PDUFA comparison.

 

7.  Although the timing of future approvals from these cohorts is not yet known, their count for purposes of the median calculation is projected from prior cohorts. Based on the GAO study data, mean approval times for these recent cohorts will likely be about two months longer than the median measures.

 

8.  "Affirmative" actions are defined here as the sum of approval actions and approvable actions.

 


Appendix A

PDUFA Performance Goals, FY 1993 - FY 1997

The following list presents by fiscal year the performance measures set forth in the letters referenced in Section 102(3) of the PDUFA. In those letters, the timing of a number of the goals was conditional either (1) on the date (July 2, 1993) upon which a supplemental appropriation was enacted to permit FDA to collect PDUFA user fees, or (2) a specific performance interval (e.g., 6 or 12 months after submission). The following chart lists the 29 goals by fiscal year with appropriate goal measurement dates:

 

Interim Goals by Fiscal YearTiming of MeasurementMeasurement Date [1]
Interim Goals of FY 93
1. Establish an industry/FDA working group upon initiation of the user fee program.Supplemental appropriation dateJuly 2, 1993
2. Initiate a pilot computer-assisted PLA review (CAPLAR) program during FY 93End of FY 93Sept. 30, 1993
Interim Goals of FY 94
1. Review and act upon 55 percent of complete NDA and PLA/ELA submissions received during FY 94 within 12 months after submission date.12 months after end of FY 94Sept. 30, 1995
2. Review and act upon 55 percent of efficacy supplements [2] received during FY 94 within 12 months after submission date.12 months after end of FY 94Sept. 30, 1995
3. Review and act upon 55 percent of manufacturing supplements [2] received during FY 94 within 6 months after submission date.6 months after end of FY 94Mar. 31, 1995
4. Review and act upon 55 percent of resubmitted applications received during FY 94 within 6 months after the resubmission date.6 months after end of FY 94Mar. 31, 1995
5. Implement performance tracking and monthly monitoring of CBER performance within 6 months of initial user fee payments.6 months after 7/2/93Jan. 2, 1994
6. Implement project management methodology for all NDA reviews within 12 months of the initiation of user fee payments.12 months after 7/2/93July 2, 1994
Interim Goals of FY 95
1. Review and act upon 70 percent of complete NDA and PLA/ELA submissions received during FY 95 within 12 months after submission date.12 months after end of FY 95Sept. 30, 1996
2. Review and act upon 70 percent of efficacy supplements received during FY 95 within 12 months after submission date.12 months after end of FY 95Sept. 30, 1996
3. Review and act upon 70 percent of manufacturing supplements received during FY 95 within 6 months after submission date.6 months after end of FY 95Mar. 31, 1996
4. Review and act upon 70 percent of resubmitted applications received during FY 95 within 6 months after the resubmission date.6 months after end of FY 95Mar. 31, 1996
5. Recruit and bring on board 50 percent of FDA incremental review staff by first quarter of FY 95.3 months after end of FY 94Dec. 31, 1994
6. Implement project management methodology for all PLA/ELA reviews within 18 months of user fee payments.18 months after 7/2/93Jan. 2, 1995
7. Eliminate overdue backlogs of efficacy and manufacturing supplements to NDAs withn 18 months of initiation of user fee payments.18 months after 7/2/93Jan. 2, 1995
8. Eliminate overdue backlogs of NDAs within 24 months of initiation of user fees.24 months after 7/2/93July 2, 1995
9. Eliminate overdue backlogs of PLAs, ELAs and PLA/ELA supplements within 24 months of initiation of user fees.24 months after 7/2/93July 2, 1995
10. Adopt uniform computer-assisted NDA standards during FY 95End of FY 95Sept. 30, 1995
Interim Goals of FY 96
1. Review and act upon 80 percent of complete NDA and PLA/ELA submissions received during FY 96 within 12 months after submission date.12 months after end of FY 96Sept. 30, 1997
2. Review and act upon 80 percent of efficacy supplements received during FY 96 within 12 months after submission date.12 months after end of FY 96Sept. 30, 1997
3. Review and act upon 80 percent of manufacturing supplements received during FY 96 within 6 months after submission date.6 months after end of FY 96Mar. 31, 1997
4. Review and act upon 80 percent of resubmitted applications received during FY 96 within 6 months after the resubmission date.6 months after end of FY 96Mar. 31, 1997
Five-Year Goals of FY 97
1. Review 90 percent of complete PLAs, ELAs, and NDAs for priority applications within 6 months after submission date.6 months after end of FY 97Mar. 31, 1998
2. Review 90 percent of complete PLAs, ELAs, and NDAs for standard applications within 12 months after submission date.12 months after end of fY 97Sept. 30, 1998
3. Review 90 percent of priority supplements to PLAs, ELAs, and NDAs within 6 months after submission date.6 months after end of FY 97Mar. 31, 1998
4. Review 90 percent of standard supplements to PLAs, ELAs, and NDAs that require review of clinical data (efficacy supplements) within 12 months after submission.12 months after end of FY 97Sept. 30, 1998
5. Review 90 percent of supplements to PLAs, ELAs, and NDAs that do not require review of clinical data (manufacturing supplements) within 6 months after submission date.6 months after end of FY 97Mar. 31, 1998
6. Review 90 percent of complete applications resubmitted following receipt of a non-approval letter within 6 months after the resubmission date.6 months after end of FY 97Mar. 31, 1998
7. Total review staff increment recruited and on board by end of FY 97.End of FY 97Sept. 30, 1997

 


Footnotes

  1. The statute allows three additional months for review of original NDA, PLA, or ELA submissions that involve major amendments within the last three months of their usual 6- or 12-month review intervals. In these cases, the measurement dates shown in this Appendix move forward by 3 months.

     

  2. The term "supplement" applies to both drug and biologic submissions. It includes "amendments" to biologic submissions.

 


Appendix B: Approval History of FY 93 and FY 94 Cohorts

This appendix presents the NDA and PLA approvals for the FY 93 and FY 94 cohorts. Table 1 presents the priority approvals for the FY 93 cohort; Table 2 the FY 93 standard approvals; Table 3 the FY 94 priority approvals; and Table 4 the FY 94 standard approvals.

 

TERMS AND CODING USED IN TABLES
NEWThe list includes all cohort drug approvals through September 30, 1995; thus approvals from prior years are included. Drugs marked with NEW are those approved during FY 95.
*May not appear to add to total due to rounding
**Major amendment was received within 3 months of the action due date, which extended the review time frames by 3 months
 Action Codes: NA = Not Approvable; AE = Approvable; AP = Approval

 

 

Table 1: Priority NDA and PLA Approvals—FY 93 Cohort
(Approvals from September 1, 1992 - September 30, 1995)


Table 1: Priority NDA and PLA Approvals—FY 93 Cohort
(Approvals from September 1, 1992 - September 30, 1995)
Generic NameSponsorApproval Time (Months)Review Goal Met
Total Time*Resubmissions (if necessary)

 
LEVOMETHADYL ACETATE HCLBiodevelopment0.6
 
Y

 
FENTANYL CITRATEAnesta4.3
 
Y

 
TACROLIMUS InjectableFujisawa USA8.1
 
Y

 
TACROLIMUS CapsulesFujisawa USA8.4
 
Y

 
DORNASE ALFA (PLA)Genentech, Inc.9.0
 
Y

 
IMIGLUCERASEGenzyme12.1
 
N

 
APROTININMiles Pharmaceutical13.21st Action: 7.2 (AE)
Sponsor Response: 5.5
2nd Action: 0.5 (AP)
Y

Y

 
MENTROPINOrganon14.9
 
Y**
NEWMETFORMIN HYDROCHLORIDEBristol Myers Squibb15.0
 
Y**
NEWVINORELBINE TARTRATEBurroughs Wellcome15.91st Action: 14.9 (AE)
Sponsor Response: 0.3
2nd Action: 0.7 (AP)
Y**

Y

 
FLUDEOXYGLUCOSE F-18Downstate Clinical19.0
 
N

 
RHO(D) IMMUNE GLOBULIN INTRAVENOUS (HUMAN) (PLA)Rh Parmaceuticals Inc.21.71st Action: 13.8 (NA)
Sponsor Response: 1.1
2nd Action: 6.8 (AP)
N

N

 

 

FY 93 Priority Applications: Summary Statistics for Approvals

FY 93 Priority Applications: Summary Statistics for Approvals
Average First Review Time (n=12)10.6 months
Average Sponsor Response Time (n=3)2.3 months
Average Second Review Time (n=3)2.7 months
Average Total Approval Time (n=12)11.8 months

 

 

Table 2: Standard NDA and PLA Approvals—FY 93 Cohort
(Approvals from September 1, 1992 - September 30, 1995)


Table 2: Standard NDA and PLA Approvals—FY 93 Cohort
(Approvals from September 1, 1992 - September 30, 1995)
Generic NameSponsorApproval Time (Months)Review Goal Met
Total Time*Resubmissions (if necessary)

 
DESOGESTREL/ETHINYL ESTRADIOLJohnson RW2.2
 
Y

 
SOMATROPIN, BIOSYNTHETICGenentech, Inc.4.2
 
Y

 
DOBUTAMINE HYDROCHLORIDEBaxter Healthcare6.91st Action: 3.2 (NA)
Sponsor Response: 3.1
2nd Action: 0.6 (AP)
Y

Y

 
ROCURONIUM BROMIDEOrganon8.61st Action: 6.4 (AE)
Sponsor Response: 1.0
2nd Action: 1.2 (AP)
Y

Y

 
TRIMETREXATEU.S. Bioscience10.0
 
Y

 
CLOTRIMAZOLEMiles Pharmaceutical10.41st Action: 7.3 (AE)
Sponsor Response: 0.6
2nd Action: 2.4 (AP)
Y

Y

 
TIMOLOL MALEATEMerck10.91st Action: 6.5 (AE)
Sponsor Response: 1.1
2nd Action: 3.3 (AP)
Y

Y

 
DESMOPRESSIN ACETATERhone Poulenc Rorer11.5
 
Y

 
FAMCICLOVIRSmithKline Beecham12.0
 
Y

 
ISONIAZID/PYRAZINAMIDE/
RIFAMPIN
Marion Merrell12.4
 
N

 
NAPROXEN SODIUMHamilton12.8
 
N

 
BUDESONIDEAstra13.51st Action: 11.5 (AE)
Sponsor Response: 0.4
2nd Action: 1.5 (AP)
Y

Y

 
CLARITHROMYCINAbbott Labs13.7
 
Y**
NEWIBUPROFEN Chewable TabletsMcNeil14.4
 
N
NEWESTRADIOL TRANSDERMAL SYSTEM3M Pharm.14.7
 
Y**

 
GLIPIZIDE EXTENDED RELEASEPfizer15.8
 
N**

 
CLOBETASOL PROPIONATE GelGlaxo16.41st Action: 12.0 (AE)
Sponsor Response: 0.7
2nd Action: 3.7 (AP)
Y

Y

 
ISRADIPINESandoz Pharmaceutical17.01st Action: 12.0 (AE)
Sponsor Response: 0.2
2nd Action: 4.8 (AP)
Y

Y
NEWTERAZOSIN HYDROCHLORIDEAbbott17.61st Action: 12.9 (AE)
Sponsor Response: 0.3
2nd Action: 4.4 (AP)
N

Y

 
CLOBETASOL PROPIONATE CreamGlaxo17.81st Action: 12.0 (AE)
Sponsor Response: 0.6
2nd Action: 5.2 (AP)
Y

Y
NEWIBUPROFEN 200 mg capsulesSandoz18.7
 
N
NEWFLUTICASONE PROPIONATEGlaxo18.81st Action: 16.8 (AE)
Sponsor Response: 1.4
2nd Action: 0.6 (AP)
N

Y

 
INDIUM IN—111 PENTETATEMallinckrodt19.3
 
N**

 
MILRINON LACTATESterling Winthrop19.31st Action: 3.6 (NA)
Sponsor Response: 7.1
2nd Action: 1.2 (AE)
Sponsor Response: 1.8
3rd Action: 5.5 (AP)
Y

Y

Y
NEWGRANISETRON HYDROCHLORIDESmithKline Beecham19.51st Action: 7.1 (NA)
Sponsor Response: 1.3
2nd Action: 5.7 (AE)
Sponsor Response: 0.6
3rd Action: 4.9 (AP)
Y

Y

Y
NEWAMLODIPINE BESYLATE/
BENAZEPRIL HYDROCHLORIDE
Ciba Geigy20.11st Action: 13.0 (AE)
Sponsor Response: 3.9
2nd Action: 3.2 (AP)
Y**

Y

 
MAGNESIUM SULFATEAbbott20.11st Action: 6.9 (NA)
Sponsor Response: 5.8
2nd Action: 7.4 (AP)
Y

N
NEWVARICELLA VIRUS VACCINE LIVE (PLA)Merck & Co., Inc.22.01st Action: 11.5 (NA)
Sponsor Response: 1.5
2nd Action: 9.0 (AP)
Y

N
NEWESTRADIOLCiba Geigy22.11st Action: 15.0 (AE)
Sponsor Response: 5.5
2nd Action: 1.7 (AP)
Y**

Y
NEWNISOLDIPINEZeneca22.11st Action: 11.8 (NA)
Sponsor Response: 4.3
2nd Action: 6.0 (AP)
Y

Y
NEWIOPAMIDOLBracco Dxs22.31st Action: 12.5 (NA)
Sponsor Response: 3.9
2nd Action: 5.9 (AP)
N

Y
NEWDALTEPARIN SODIUMPharmacia23.71st Action: 12.4 (AE)
Sponsor Response: 9.0
2nd Action: 2.3 (AP)
Y**

Y
NEWFAMOTIDINEMerck24.91st Action: 24.5 (AE)
Sponsor Response: 0.2
2nd Action: 0.1 (AP)
N**

Y
NEWDIRITHROMYCINLilly25.71st Action: 15.0 (AE)
Sponsor Response: 7.0
2nd Action: 3.7 (AP)
Y**

Y
NEWMOEXIPRIL HYDROCHLORIDESPKU28.01st Action: 17.0 (AE)
Sponsor Response: 9.9
2nd Action: 1.1 (AP)
N

Y
NEWMETRONIDAZOLESearle28.61st Action: 12.0 (AE)
Sponsor Response: 10.8
2nd Action: 5.8 (AP)
Y**

Y
NEWCARVEDILOLSmithKline Beecham29.5
 
N
NEWCALCITONIN-SALMONSandoz32.11st Action: 25.9 (AE)
Sponsor Response: 1.2
2nd Action: 5.0 (AP)
N

Y
NEWCALCIUM MUPIROCINSmithKline Beecham32.61st Action: 14.9 (AE)
Sponsor Response: 3.8
2nd Action: 6.0 (AE)
Sponsor Response: 3.1
3rd Action: 4.8 (AP)
Y**

Y

Y

 

 

FY 93 Standard Applications: Summary Statistics for Approvals

FY 93 Standard Applications: Summary Statistics for Approvals
Average First Review Time (n=39)12.7 months
Average Sponsor Response Time (n=28)3.2 months
Average Second Review Time (n=25)3.7 months
Average Total Approval Time (n=39)17.7 months

 

 

Table 3: Priority NDA and PLA Approvals—FY 94 Cohort
(Approvals from October 1, 1993 - September 30, 1995)


Table 3: Priority NDA and PLA Approvals—FY 94 Cohort
(Approvals from October 1, 1993 - September 30, 1995)
Generic NameSponsorApproval Time (Months)Review Goal Met
Total Time*Resubmissions (if necessary)
NEWATOVAQUONEBurroughs Wellcome5.8
 
Y
NEWGANCICLOVIRSyntex5.8
 
Y

 
STAVUDINEBristol Myers Squibb5.9
 
Y
NEWRIMEXOLONEAlcon7.0
 
Y

 
CYSTEAMINE BITARTRATEMylan8.71st Action: 8.2 (AE)
Sponsor Response: 0.4
2nd Action: 0.2 (AP)
Y

Y
NEWPLAGUE VACCINE (PLA)Greer Laboratories, Inc.11.51st Action: 2.3 (NA)
Sponsor Response: 1.2
2nd Action: 2.9 (NA)
Sponsor Response: 2.4
3rd Action: 2.7 (AP)
Y

Y

Y
NEWDORZOLAMIDE HYDROCHLORIDEMerck12.0
 
Y
NEWABCIXIMAB (PLA)Centocor B. V.12.21st Action: 6.0 (NA)
Sponsor Response: 1.7
2nd Action: 4.5 (AP)
Y

Y
NEWALPROSTADILUpJohn16.71st Action: 11.9 (NA)
Sponsor Response: 0.4
2nd Action: 4.4 (AP)
Y

Y
NEWEPOPROSTENOL SODIUMBurroughs Wellcome18.71st Action: 14.3 (AE)
Sponsor Response: 2.6
2nd Action: 1.8 (AP)
Y**

Y

 

 

FY 94 Priority Applications: Summary Statistics for Approvals

FY 94 Priority Applications: Summary Statistics for Approvals
Average First Review Time (n=10)7.9 months
Average Sponsor Response Time (n=6)1.4 months
Average Second Review Time (n=5)2.8 months
Average Total Approval Time (n=10)10.4 months

 

 

Table 4: Standard NDA and PLA Approvals—FY 94 Cohort
(Approvals from October 1, 1993 - September 30, 1995)


Table 4: Standard NDA and PLA Approvals—FY 94 Cohort
(Approvals from October 1, 1993 - September 30, 1995)
Generic NameSponsorApproval Time (Months)Review Goal Met
Total Time*Resubmissions (if necessary)
NEWSEVOFLURANEAbbott10.9
 
Y
NEWCYCLOSPORINE MICROEMULSION SolutionSandoz11.6
 
Y
NEWCYCLOSPORINE MICROEMULSION CapsulesSandoz11.6
 
Y
NEWNALMEFENE HYDROCHLORIDEOhmeda11.6
 
Y
NEWMETRONIDAZOLE TOPICAL CREAMGalderma11.7
 
Y
NEWIBUPROFEN Oral dropsMcNeil11.8
 
Y
NEWNAPROXENSyntex11.9
 
Y
NEWACARBOSEBayer12.0
 
Y
NEWESTROGENS, CONJ'D/ MEDROXYWyeth Ayerst12.0
 
Y
NEWIBUPROFEN 100 mg tabletsMcNeil12.0
 
Y
NEWMAGNESIUM SULFATE IV 10 mgAbbott12.0
 
Y
NEWTESTOSTERONE TRANSDERMALTheratech12.0
 
Y**
NEWVALACYCLOVIR HCLBurroughs Wellcome12.0
 
Y
NEWTIMOLOL HEMIHYDRATE OPTHALMICLeiras13.41st Action: 10.4 (NA)
Sponsor Response: 1.2
2nd Action: 1.9 (AP)
Y**

Y
NEWDINOPROSTONE VAGINAL INSERTControlled Ther15.0
 
Y**
NEWTRAMADOL HYDROCHLORIDEJohnson RW15.51st Action: 15.0 (AE)
Sponsor Response: 0.2
2nd Action: 0.2 (AP)
Y**

Y
NEWONDANSETRON HCL DIHYDRATEGlaxo15.81st Action: 6.6 (NA)
Sponsor Response: 1.4
2nd Action: 4.9 (AE)
Sponsor Response: 2.6
3rd Action: 0.4 (AP)
Y

Y

Y
NEWLOSARTAN POTASSIUMMerck16.31st Action: 14.9 (AE)
Sponsor Response: 1.3
2nd Action: 0.1 (AP)
Y**

Y
NEWLOSARTAN POTASSIUM/ HYDROCHLOROTHIAZIDEMerck16.61st Action: 15.0 (AE)
Sponsor Response: 1.6
2nd Action: 0.1 (AP)
Y**

Y
NEWLANSOPRAZOLETap Holdings17.81st Action: 15.0 (AE)
Sponsor Response: 1.9
2nd Action: 0.9 (AP)
Y**

Y
NEWAZELAIC ACIDAllergan18.51st Action: 12.0 (NA)
Sponsor Response: 0.4
2nd Action: 6.0 (AP)
Y

Y
NEWAMIODARONE HYDROCHLORIDEWyeth Ayerst19.21st Action: 13.5 (AE)
Sponsor Response: 0.8
2nd Action: 1.6 (AE)
Sponsor Response: 0.7
3rd Action: 2.6 (AP)
Y**

Y

Y
NEWCISAPRIDEJanssen22.51st Action: 9.2 (NA)
Sponsor Response: 2.6
2nd Action: 7.5 (AE)
Sponsor Response: 2.5
3rd Action: 0.6 (AP)
Y

N
Y

 

 

FY 94 Standard Applications: Summary Statistics for Approvals

FY 94 Standard Applications: Summary Statistics for Approvals
Average First Review Time (n=23)12.2 months
Average Sponsor Response Time (n=12)1.4 months
Average Second Review Time (n=9)2.6 months
Average Total Approval Time (n=23)14.1 months