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FY 2002 PDUFA Performance Report

Print version of this report

 


Table of Contents

Commissioner's Report

Executive Summary

Introduction

Overview of PDUFA

PDUFA I Outcomes 

PDFUA II Outcomes 

PDFUA III Commitments

Report on PDUFA Goals:

Original New Product Applications 

Resubmitted New Product Applications 

Efficacy Supplements 

Manufacturing Supplements 

Procedural and Processing Goals

Notes

Appendices:

APPENDIX A:PDUFA Performance Goals (FY 1998 - FY 2002)

APPENDIX B:List of Approved Applications

 


Commissioner's Report

I am pleased to submit the Food and Drug Administration's (FDA's) FY 2002 Performance Report to Congress for the Prescription Drug User Fee Act (PDUFA). All of the original applications submitted during FY 2001 have been reviewed and acted upon and final performance data can now be reported. Only a preliminary performance assessment on applications submitted during FY 2002 is possible at this time.

During FY 2001, FDA met and in many cases exceeded our PDUFA performance goals. Since Congress first authorized user fees for new drug review in 1992, FDA has consistently met increasingly tougher PDUFA performance goals. As a result, patients are getting the benefit of new drugs more quickly. As the Tufts Center for the Study of Drug Development said near the end of PDUFA II, "The change in the environment for pharmaceutical innovation in the United States that has occurred since passage of PDUFA has been nothing short of remarkable." Last year Congress renewed the program for another five years as PDUFA III to continue and build on FDA's success.

Agency-wide initiatives to speed development of new medical technologies will be a major thrust in FDA's new strategic plan. During calendar year 2002, FDA approved a large number of new products, many of which represent significant advances for patients and physicians by providing new options to treat serious, disabling, or life threatening diseases. Counterbalancing this positive news from 2002 are some trends showing decreases in the submission of new applications for truly innovative new products.

The trend of declining numbers of these 'new' products presents a challenge to both industry product developers and to FDA, whose mission includes increasing patient access to safe and effective new products. FDA has committed to achieving measurable long-term improvements in disease outcomes; this can only be accomplished by enabling successful new technology development.

Performance in terms of approval times for drugs and biologics approved in calendar year 2002 was mixed, with some decreasing and some increasing. FDA is focusing on reducing the longer approval times that result from multiple review cycles where additional information is needed before an application is approved. There may be steps that FDA can take to help product sponsors submit applications that "get it right the first time," providing the safety and effectiveness data required for approval without the cost and effort of multiple review cycles.

FDA plans to take steps to address both the longer times to approval and the lower numbers of applications for truly new and innovative products. We recently announced initiatives to reduce the total time and cost of developing and approving safe and effective new products. The initiatives fall into three categories:

  • Identifying the "root causes" of multiple review cycles and implementing steps to avoid them where possible, for example through early communication and other steps to improve the quality of new product applications
  • Improving the quality and efficiency of the review process by adopting a quality systems approach to medical product reviews
  • Improving the quality of submissions in new and priority product areas by providing clearer guidance for particular diseases and for emerging technologies

These initiatives do not represent fundamental changes in the way we do business. Rather, they build on initiatives that FDA has already tested or implemented successfully. All are focused on making sure that our expert reviewers have the best support possible so they can review applications quickly and efficiently, and thus speed new medical products to American patients and practitioners without sacrificing FDA's traditionally high standards for safety and effectiveness.

Mark B. McClellan, M.D., Ph.D.
Commissioner of Food and Drugs


Executive Summary

In 1992, Congress enacted the Prescription Drug User Fee Act (PDUFA). PDUFA provided FDA with additional resources to hire more medical and scientific reviewers to conduct premarket reviews as well as support staff and field investigators to speed up the application review process for human drug and biological products. In 1997, after a successful first five years, Congress reauthorized the program for five additional years (PDFUA II). Last year, Congress again extended PDUFA for five more years (PDUFA III). Each reauthorization has brought higher expectations for reviews and additional goals intended to improve FDA's responsiveness to and communication with industry sponsors. As a result of PDUFA, FDA has significantly reduced the review and approval times for new drug and biologic applications without compromising FDA's traditionally high standards for approval of new drugs and biologics.

All of the original applications submitted during FY 2001 have been reviewed and acted upon, and final performance data can now be reported. Only a preliminary performance assessment on applications submitted during FY 2002 is possible at this time. FDA exceeded all the review performance goals for original and resubmitted new drug and biological applications and for standard efficacy supplements and manufacturing supplements submitted in FY 2001. With regard to priority efficacy supplements submitted in FY 2001, FDA failed to meet the review goal for one of nine supplements, and thus failed to meet the 90 percent on time performance goal. Although it is too early to report final results, the Agency appears to be meeting or exceeding all the application review goals for FY 2002 submissions. In FY 2002, the Agency met or exceeded three of the six "procedural and processing" goals designed to improve its responsiveness to sponsor requests during the early phases of drug development.

Notwithstanding the successes noted above, the Agency encountered significant challenges in trying to meet the PDUFA II goals. The revenue the Agency collected from fees during PDUFA II was significantly less than expected due to a reduction in the number of new drug and biologic applications submitted and an increase in the proportion of applications that met the criteria for fee waivers. This decrease in resources combined with a continuing increase in overall workload under PDUFA resulted in significant stress to the program during the last few years of PDUFA II. The recently reauthorized PDUFA III aims to correct the balance between resources and workload over the first several years of the program, while further challenging the Agency with additional performance commitments.

Through all these reauthorizations, the goal of PDUFA has remained unchanged. The industry and FDA, working together, are bringing safe and effective new medicines to American patients and practitioners quickly without compromising FDA's traditionally high standards for safety, effectiveness, and product quality.

 


Introduction

In 1992, Congress passed the Prescription Drug User Fee Act (PDUFA). PDUFA authorized FDA to collect fees from companies that produce and submit applications for marketing for human drug and biological products. The original PDUFA had a five-year life; it ended in 1997, the same year Congress passed the FDA Modernization Act (FDAMA). FDAMA contained a five-year reauthorization of PDUFA (PDUFA II). PDUFA II ended on September 30, 2002. Last year, Congress passed the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which extended PDUFA for an additional five years (PDUFA III). Information about PDUFA III, including the text of the amendments and the performance goals and procedures, can be found at http://www.fda.gov/oc/PDUFA/5yrplan.html

 

PDUFA 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 2002.

 


Overview of PDUFA

September 30, 2002 marked the end of 10 years of FDA experience with PDUFA. PDUFA has provided FDA with additional revenue to hire more reviewers and support staff and upgrade its information technology systems to speed up the application review process for new drugs and biological products without compromising FDA's traditionally high standards for approval. Under PDUFA, FDA agreed to meet certain performance goals that apply to the review of original and resubmitted new product applications and efficacy and manufacturing supplements to approved applications. FDA also agreed to meet certain procedural and processing goals aimed at speeding-up drug development. These goals were designed to become increasingly more stringent each year. To date, FDA has met or exceeded nearly every review performance goal and most of the procedural and processing goals.

 


PDUFA I Outcomes: New Resources and Approaches Result in Approval of New Products Sooner

The original PDUFA (PDUFA I) was generally regarded as an unqualified success. During the first few years of PDUFA I, FDA eliminated overdue backlogs of New Drug Applications (NDAs), Biological License Applications (BLAs -- originally referred to as Product License Applications (PLAs) and Establishment License Applications (ELAs)), and both efficacy and manufacturing supplements to NDAs and BLAs. FDA also implemented performance tracking in the Center for Biologics Evaluation and Research (CBER), project management methodology for NDA and BLA reviews, and adopted uniform standards for computer assisted NDAs.

New Directions. Over the course of PDUFA I, the Agency agreed to review and act upon a progressively increasing proportion of original NDAs, BLAs, and efficacy supplements within 12 months and resubmissions and manufacturing supplements within 6 months. The proportion of each type of submission the Agency agreed to review within specified time constraints increased from 55 percent for FY 94 submissions to 90 percent for FY 97 submissions. In addition, the Agency agreed to review and act upon 90 percent of priority NDAs, BLAs, and efficacy supplements (i.e., submissions for products providing significant therapeutic gains) submitted in FY 97 within 6 months. Over the course of PDUFA I, FDA exceeded all of these performance goals.

Success Leads to Immediate Results. As a direct result of the FDA's quicker and more predictable review performance, and the improved communication between FDA and application sponsors that PDUFA fostered, new products were approved at an unprecedented pace without compromising FDA's traditionally high standards for safety, effectiveness, and quality. Under PDUFA I:

  • Median total approval times1 for NDAs and BLAs dropped from 20 months to 12 months.
  • The percentage of filed NDAs and BLAs that ultimately were approved increased from approximately 66 percent in the pre-PDUFA years to 80 percent after PDUFA.
  • The number of original applications the Agency refused to file, a key measure of submission quality, dropped from 34 in FY 93 to just 2 in FY 97.
  • The number of NDAs and BLAs submitted and filed each year increased from 88 in FY 93 to 130 in FY 97.

 


PDUFA II Outcomes: Continued Success, Unexpected Challenges

In 1997, Congress passed the Food and Drug Administration Modernization Act (FDAMA). Part of FDAMA reauthorized PDUFA (PDFUA II) for five additional years, FY 98 through FY 02. Under PDUFA II, the review goals continued to shorten. For submissions received in FY 2002, the PDUFA II goals called for FDA to review and act on 90 percent of:

  • Priority new drug and biological product applications and efficacy supplements within 6 months;
  • Standard new drug and biological product applications and efficacy supplements within 10 months;
  • Manufacturing supplements within 6 months, and those requiring prior approval within 4 months;
  • Class 1 resubmissions of original applications within 2 months, and Class 2 resubmissions of original applications within 6 months (Definitions of Class 1 and Class 2 resubmissions can be found at the end of Appendix A.).

In addition, PDUFA II added a new set of goals intended to improve FDA's responsiveness to and communication with application sponsors during the drug development process. These goals specified timeframes for activities such as scheduling meetings and responding to various sponsor submissions such as special protocols and responses to clinical holds. Whereas PDUFA I's intent was to speed up the review process, PDUFA II's intent was to speed up the entire drug development process.

Continued Success. The Agency has met or exceeded nearly all the PDUFA II application review goals every year. The only review goals missed were for priority efficacy supplements submitted in FY 00 and FY 01 where on-time performance fell just short of the 90 percent goal. The Agency has been less successful in meeting the procedural and processing goals, although it has met or exceeded most.

Under PDUFA II, the Agency's review performance continued to accelerate and communication with and responsiveness to sponsor requests during the drug development phase improved. Several important outcomes accrued:

  • During the early years of PDUFA II, approval times continued to improve. The median time to approval for original priority applications submitted in FY99 was 6 months. For original standard applications submitted that year, the median approval time was 12 months.
  • More New Molecular Entities (NMEs) were introduced in the U.S. first. Before PDUFA, FDA approved about 40 percent of the NMEs introduced on the world market either first or within 1 year of their introduction in another country. After PDUFA, that percentage nearly doubled providing Americans with more rapid access to safe and effective new drugs.

Unexpected Challenges.

 

"Graph Description"D

 

During PDUFA I the number of original applications submitted to the Agency increased at a steady pace each year. During PDUFA II the number of original applications decreased from the levels predicted based on PDUFA I, and more of these applications were either exempt from fees or met the criteria for waiver of fees. As a result, during the last few years of PDUFA II, fee revenue was less than the Agency and Congress had predicted when PDUFA was reauthorized in 1997 while total FDA workload under PDUFA continued to increase. This imbalance between resources and workload resulted in significant stress to the program.


"Graph Description"D

 

During the last years of PDUFA II:

  • Median approval times for NDAs and BLAs began to increase. For standard applications submitted in FY 2000, median total approval time increased to 14.8 months. Although it is too soon to make even a preliminary assessment for standard applications submitted in FY 2001, based on the applications approved by September 30, 2002 and the queue of unapproved applications, it appears that the median approval time for the FY 2001 cohort will be even higher. The median approval time for priority applications submitted in FY 2001 is estimated to be 9.8 months based on applications approved by September 30, 2002. This increase in median approval time for priority applications occurred despite a decrease in the number of priority applications submitted to the Agency. Compared with earlier years when more than 30 priority applications were filed annually, only 13 priority applications were filed in FY 2001. Only two of these were approved on the initial review, whereas, in previous years, more than half of the priority NDAs and BLAs were approved on the initial review.
  • Some FDA stakeholders, and recently the General Accounting Office2 (GAO) have expressed concerns about the number of drugs approved under PDUFA that have been withdrawn for safety reasons. However, an analysis of the rate of withdrawal for safety reasons of New Molecular Entities approved prior to PDUFA compared to those approved under the PDUFA program shows no significant difference (2.7% for drugs approved pre-PDUFA and 2.5% for drugs approved under PDUFA3. While FDA's standards for safety have not changed under PDUFA, the total number of drug and biologic products on the U.S. market has increased substantially, and many of these products are being approved first in the U.S. As a result of this heightened awareness, the importance of rigorous post-market surveillance of recently approved products has increased under PDUFA.

PDUFA III Commitments: New Goals and Approaches

Last year, Congress passed the Bioterrorism Act, which included an extension of PDUFA (PDUFA III) for an additional five years. By authorizing increased user-fees, the goal of PDUFA III is to bring revenue and resources back into balance with the increasing total PDUFA workload. This rebalancing, however, will take several years as FDA recruits and trains new review and support staff.

PDUFA III retains the review performance goals and the procedural and processing goals of PDUFA II essentially unchanged from their FY 2002 performance levels. It adds one new review goal, establishes several pilot efforts to further speed the review process, and for the first time authorizes FDA to expend user-fee revenue on certain post-market safety activities. Detailed information about PDUFA III, including the text of the amendments and the performance goals and procedures can be found at www.fda.gov/oc/pdufa/PDUFA3.html. The additional challenges and commitments the Agency faces under PDUFA III include:

  • A new and increasingly stringent set of review performance goals for resubmitted efficacy supplements. By FY 2007 FDA will review and act upon 90 percent of Class 1 efficacy supplement resubmissions within 2 months and 90 percent of Class 2 efficacy supplement resubmissions within 6 months.
  • The establishment and evaluation of two pilot programs to explore the continuous marketing application concept, which are expected to further decrease drug development and review times for Fast Track drugs and biologics. Under these pilot programs FDA will provide sponsors with earlier and more frequent feedback and interactions during the drug development phase and expand the use of rolling reviews for certain Fast Track products.
  • A variety of new risk management initiatives including the submission and review of risk management plans as part of pre-NDA/BLA meetings and as part of original NDA/BLA applications. In addition, FDA will be allowed to use fee revenue for the first time for post-approval safety activities. Finally, FDA has committed to develop and publish guidances to industry on Good Risk Assessment, Good Risk Management, and Good Pharmacovigilance.
  • The limited use of independent consultants, at the sponsor's request, for biotechnology clinical trial protocol review for products that represent a significant advance or address an unmet medical need.
  • Several initiatives to improve FDA performance management including:
    • Developing guidance on good review management principles;
    • Notifying sponsors of issues identified during the filing review;
    • Contracting with an outside consultant for a comprehensive review and analysis of the drug and biologic review process; and
    • Further studies of program design, performance features, and costs, including a re-analysis of program costs under PDUFA III.
  • A variety of information technology initiatives aimed at developing centralized and uniform information systems to simplify and enhance the use of electronic applications and submissions.

As the progression of performance commitments under PDUFA makes clear, continuing to speed drug development and review while preserving and even raising FDA's high standards for safety, effectiveness, and product quality, is becoming increasingly difficult. Under PDUFA I, the Agency improved its performance by shortening review times. Under PDUFA II, the Agency continued to shorten review times and also improved its responsiveness to sponsors during the drug development phase. PDUFA III maintains the gains of the past, but commits the Agency to finding new ways to improve the entire review process, from drug development through application review and into the post-market surveillance period. Underscoring all of these commitments is the Agency's commitment to the American people -- to work with application sponsors and our stakeholders to bring effective new drug products to market as quickly as possible without sacrificing the high standards for safety that practitioners and patients rely on.

 


Report on FY 2001 and 2002 PDUFA Goals

This report updates the Agency's review performance on the FY 2001 application submissions and evaluates its performance in reviewing FY 2002 application submissions and meeting other PDUFA II goals. All of the original applications submitted during FY 2001 have been reviewed and acted upon, and final performance data can now be reported. Only a preliminary performance assessment on applications submitted during FY 2002 is possible at this time. 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. Unless otherwise noted, all performance data in this section are as of September 30, 2002.

FDA's Center for Biologics Evaluation and Research (CBER) has changed from counting Product License Applications (PLAs) and Establishment License Applications (ELAs) separately to combining them as Biologic License Applications (BLAs). This report shows CBER's workload and performance on PLAs and BLAs only (i.e., Product Applications). To simplify notation, it uses BLA as a generic term for both BLAs and PLAs. Original and resubmitted ELAs have been dropped, both from workload counts and performance measurements. These new counts are reflected in the workload and performance data for the PDUFA I years, so trends into PDUFA II are consistent.

 


Report on PDUFA Goals: Original New Product Applications

Goal --Review and act upon complete original NDAs and BLAs

The table below summarizes the annually decreasing review-time goals for original New Drug Applications (NDAs) and BLAs under PDUFA II. Over the five-year period, the goal of reviewing 90 percent of priority applications in six months remained constant. For standard applications, the review-time goals dropped over the five-year period. For applications filed in FY 1998, the goal was to review 90 percent in 12 months; for FY 2002 applications, the goal is to review 90 percent in 10 months. The statute allows three additional months for review of original NDA and BLA submissions that involve major amendments received within the last three months of their usual review intervals.

 

GoalsOn-Time Performance by Submission Year
FY 98FY 99FY 00FY 01FY 02
Priority6 months90% on time90%90%90%90%
Standard

12 months

10 months

90%

NA

90%

30%

90%

50%

90%

70%

NA

90%

 

Workload

The following table shows the number of original NDAs and BLAs filed in each of the last five years. The count of FY 2002 submissions assumes that all submissions received in the last two months of FY 2002 are filed. When FDA files a submission, it is deemed "complete" by PDUFA definition. FDA makes a filing decision within 60 days of an original application's receipt. All calculations of PDUFA review times are made, however, from the original receipt date of the filed application.

Original submissions filed (Priority/Standard):

 FY 98FY 99FY 00FY 01FY 024

 

NDAs 

109 (30/79)121 (30/91)121 (29/92)96 (10/86)100(9/91)

 

BLAs 

12 (8/4)6 (1/5)13 (4/9)8 (3/5)9 (3/6)

 

PDUFA Total 

121 (38/83)127 (31/96)134 (33/101)104 (13/91)109(12/97)
NMEs5
42 (19/23)41 (16/25)32 (17/15)34 (8/26)23(7/16)

Performance

 

FY 2001 Submissions

FDA met the goal of reviewing and acting upon priority applications within 6 months for all thirteen priority NDAs and BLAs filed in FY 2001. FDA also met the 12-month goal for standard submissions for 89 of the 91 standard submissions reviewed (98% on time). Ninety percent of all standard applications and 81 percent of the NMEs and BLAs were reviewed and acted upon within 10 months, exceeding the 70 percent review goal in both cases.

FY 01 Submissions

 Reviewed and acted uponNumber on timePercent on time
Priority6 month goalAll Applications1313100
NMEs & BLAs1111100
Standard12 month goalAll Applications918998*
NMEs & BLAs312994*
10 month goalAll Applications918290
NMEs & BLAs312581

* Because receipt of a major amendment extended the 10-month goal to 13 months, the two standard applications(both NMEs) that did not meet the 12-month goal met the extended 10-month goal.

 

FY 2002 Submissions

While it is too early to report meaningful review performance statistics for applications submitted in FY 2002, all priority applications that have been reviewed have met the 6-month review goal, and all standard applications that have been reviewed have met the 10-month review goal. No applications are late.

FY 02 Submissions

 Reviewed and acted uponNumber on timePercent on time
Priority6 month goalAll Applications44100
NMEs & BLAs44100
Priority10 month goalAll Applications1616100
NMEs & BLAs77100

 


Report on PDUFA Goals: Resubmitted New Product Applications

Goal--Review and act upon 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 at the end of Appendix A.

GoalsOn-Time Performance by Resubmission Year
FY 98FY 99FY 00FY 01FY 02
Class 1

6 months

4 months

2 months

90% on time

--

30%

--

90%

50%

--

90%

70%

--

--

90%

--

--

90%

Class 26 months90%90%90%90%90%

 

Workload -- Resubmissions received (Class 1/Class 2):

 FY 98FY 99FY 00FY 01FY 02
of Original NDAs50 (19/31)63 (17/46)80 (25/55)62 (25/37)62(26/36)
of Original BLAs21 (5/16)14 (2/12)9 (1/8)16 (6/10)15(2/13)
PDUFA Total71 (24/47)77 (19/58)89 (26/63)78 (31/47)77(28/49)

Performance

 

FY 2001 Resubmissions:
Twenty-eight of the 31 Class 1 resubmissions received in FY 2001 were reviewed and acted upon within 2 months, and all 47 of the Class 2 resubmissions were reviewed and acted upon within 6 months. Review performance on both classes of FY 2001 resubmissions met or exceeded the 90 percent on-time PDUFA review goals.

 

FY 01 ResubmissionsReviewed and acted uponNumber on timePercent on time
Class 12 months312890
Class 26 months4747100

 

FY 2002 Submissions:
As of September 30, 2002, 21 FY 2002 Class 1 resubmissions and 27 Class 2 resubmissions had been reviewed and acted upon. All had met their respective review goals. With 7 Class 1 and 22 Class 2 resubmissions still pending and not overdue, it is too early to make a final performance determination, but current on-time performance for both classes of resubmissions exceeds the goals.

 

FY 02 ResubmissionsReviewed and acted uponNumber on timePercent on time
Class 12 months2121100
Class 26 months2727100

 


Report on PDUFA Goals: Efficacy Supplements

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

The table below summarizes the annually decreasing review-time goals for efficacy supplements to NDAs and BLAs under PDUFA II. Review goals for efficacy supplements follow the same progression as the review goals for original NDAs and BLAs. Over the five-year period, the goal of reviewing 90 percent of priority efficacy supplements in six months remained constant. For standard efficacy supplements, the review-time goals dropped over the five-year period. For FY 1998 submissions, the goal was to review 90 percent in 12 months; for FY 2002 submissions, the goal was to review 90 percent in 10 months.

Goals

 On-Time Performance by Submission Year
FY 98FY 99FY 00FY 01FY 02
Priority6 months90% on time90%90%90%90%
Standard12 months90%90%90%90%NA
10 monthsNA30%50%70%90%

 

Workload

 

Workload -- Efficacy supplements filed (Priority / Standard):

 FY 98FY 99FY 00FY 01FY 024
to NDAs126 (10/116)135 (15/120)175 (18/157)154 (7/147)158(29/129)
to BLAs10 (1/9)10 (2/8)12 (2/10)16 (2/14)10 (3/7)
PDUFA total136 (11/125)145 (17/128)187 (20/167)170 (9/161)168 (32/136)

Performance

 

FY 2001 Submissions

Eight of the 9 priority efficacy supplements submitted in FY 2001 were reviewed and acted upon within the 6-month review goal. On-time performance was 89 percent, which is slightly below the 90 percent goal.

All of the standard efficacy supplements were reviewed and acted upon within 12 months and 91 percent were reviewed within 10 months. This performance exceeds the FY 2001 goals of 90 percent and 70 percent respectively.

FY 01 Submissions

 Reviewed and acted uponNumber on timePercent on time
Priority6 months9889
Standard12 months161161100
10 months14993

 

FY 2002 Submissions

While it is too early to report meaningful review performance statistics for efficacy supplements submitted in FY 2002, all priority efficacy supplements that have been reviewed have met the 6-month review goal and all standard efficacy supplements that have been reviewed have met the 10-month review goal. No efficacy supplements are late.

FY 02 Submissions

 Reviewed and acted uponNumber on timePercent on time
Priority6 months1313100
Standard10 months2929100

 


Report on PDUFA Goals: Manufacturing Supplements

Goal -- Review and act upon complete manufacturing supplements to NDAs and BLAs

The review performance goals for manufacturing supplements that do not require FDA approval before the changes they specify can be enacted did not change over the five years of PDUFA II. For manufacturing supplements that do require FDA's approval before the changes can be enacted, the goal times decreased from 6 months for FY 1998 submissions to 4 months for FY 2002 submissions.

GoalsOn-Time Performance by Submission Year
FY 98FY 99FY 00FY 01FY 02
Prior approval not required6 months90% on time90%90%90%90%
Prior approval required6 months90%90%90%90%NA
4 monthsNA30%50%70%90%

Workload

Workload -- Manufacturing supplements filed (Prior Approval / No Prior Approval):

 FY 98FY 99FY 00FY 01FY 02 4
to NDAs1,4631,459 (900/559)1,438 (684/754)1,474 (579/895)1,753 (622/1,131)
to BLAs371477 (259/218)587 (239/348)591 (185/406)717 (217/500)
PDUFA total1,8341,936 (1,159/777)2,025 (923/1,102)2,065 (764/1,301)2,470 (839/1,631)

Performance

 

FY 2001 Submissions

Ninety-seven percent of the manufacturing supplements submitted in FY 2001 that did not require prior FDA approval were reviewed within 6 months. That level of performance exceeded the 90 percent on-time review goal.

Ninety-seven percent of the manufacturing supplements submitted in FY 2001 that required prior FDA approval also were reviewed within 6 months. Eighty-six percent of these were reviewed within 4 months. That level of performance exceeded FY 2001's goals of 90 percent and 70 percent respectively.

FY 01 Submissions
 Reviewed and acted uponNumber on timePercent on time
Prior approval not required6 months1301126097
Prior approval required6 months76474497
4 months76465786

 

FY 2002 Submissions

As of September 30, 2002, almost 53 percent of the manufacturing supplements that do not require prior approval, and over 70 percent of those that do require prior approval had been reviewed. Ninety-eight percent those not requiring prior approval had been reviewed within the 6-month goal, and 95 percent of those that do require prior approval had been reviewed within the 4-month goal. Although it is too early to make a final determination with only 58 percent of the submissions reviewed, performance in both categories is well above the FY 2002 review goals.

FY 02 Submissions
 Reviewed and acted uponNumber on timePercent on time
Prior approval not required6 months85784398
Prior approval required4 months58555695

 


Report on PDUFA Goals: Procedural and Processing Goals

This section reports on a number of PDUFA II goals that had no precedent under PDUFA I. These goals relate to the IND phase of drug development and some aspects of the infrastructure of drug review. A detailed description of the goals, the annual performance targets, and definitions of terms can be found in Appendix A. This section reports on actions on items that occurred in FY 2002.

Meeting Management:

  • Meeting Requests: Notify requestor of formal meeting in writing within 14 days of request.
  • Scheduling Meetings: Schedule meetings within goal date (within 30 days of receipt of request for Type A meetings, 60 days for Type B meetings, and 75 days for Type C meetings). If the requested date for any of these types of meetings is greater than 30, 60, or 75 days, as appropriate, from the date the request is received by the Agency, the meeting date should be within 14 days of the requested date.
  • Meeting Minutes: Agency prepared minutes, clearly outlining agreements, disagreements, issues for further discussion and action times will be available to sponsor within 30 calendar days of meeting.
 TotalMet GoalMissed Goal6Pending Within Goal7% On Time8
On-time Goal90%
Meeting RequestsCBER414399141 
CDER107594910719 
Combined148913481212092%
Scheduling MeetingsType ACBER161411 
CDER3524101 
Type BCBER245199838 
CDER4022811129 
Type CCBER11398510 
CDER582549258 
AllCBER3743111449 
CDER101985414718 
Combined139311651616788%
Meeting MinutesCBER2912501427 
CDER971434209328 
Combined126268422335575%



 

Clinical Holds: Respond to sponsor's complete response to a clinical hold within 30 days of receipt

 TotalMet GoalMissed Goal6Pending Within Goal7% On Time8
On-time Goal90%
CBER12211237 
CDER5231183 
Combined174143211087%



 

Major Dispute Resolution: Respond to sponsor's appeal of decision within 30 days of receipt

 

 TotalMet GoalMissed Goal6Pending Within Goal7% On Tim8
On-time Goal90%
CBER4400 
CDER8800 
Combined121200100%


 

Special Protocol Question Assessment and Agreement: Respond to sponsor's request for evaluation of protocol design within 45 days of receipt

 

 TotalMet GoalMissed Goal6Pending Within Goal7% On Time8
On-time Goal90%
CBER3201 ;
CDER2451962326 
Combined248198232790%

 


 Notes on the FY 2000 PDUFA Performance Report to Congress

  1.  Total approval time is the time from the initial submission of an original application to the issuance of an approval letter for that application. It includes both FDA's review time and the time the sponsor spends answering deficiencies noted by FDA, and can encompass several review "cycles." Not all applications receive approval letters.
  2.  United States General Accounting Office, Food and Drug Administration: Effect of User Fees on Drug Approval Times, Withdrawals, and Other Agency Activities (GAO-02-958), September 2002.
  3.  Food and Drug Administration. CDER 2001 Report to the Nation: Improving Public Health Through Human Drugs. Rockville, Maryland, 2002 (p. 33). Available on the Internet at:
    • PDF - www.fda.gov/cder/reports/rtn/2001/rtn2001.pdf
    • HTML - www.fda.gov/cder/reports/rtn/2001/rtn2001.htm.
    The PDUFA figure has changed from 2.7% to 2.5% with the approval of additional NMEs this year with no additional safety based withdrawals.
  4.  The count of FY 2002 submissions assumes that all submissions received in the last two months of FY 2002 are filed. When FDA files a submission, it is deemed "complete" by PDUFA definition. FDA makes a filing decision within 60 days of an original application's receipt. All calculations of PDUFA review times are made, however, from the original receipt date of the filed application.
  5.  The term NME in this report refers exclusively to NMEs that are NDAs. For FDAMA purposes, BLAs are considered to be equivalent to NMEs; however, workload and performance statistics for BLAs are reported separately. The counts of NMEs in the workload table are of 'discrete,' filed NMEs. CDER often receives multiple submissions for the same new molecular entity, for different dosage forms for example. All are initially designated as NMEs, but, when the first of the multiples is approved, the others are redesignated as non-NMEs. In FY 2002, CDER designated 25 filings as NMEs initially (8 priority, 17 standard). Only 23 of these are 'discrete' (7 priority, 16 standard).
  6.  Includes those with late actions and those still pending whose goal date has passed and which have not had actions.
  7.  Includes actions that are pending within goal, as well as those whose goal date has passed, but whose action status is deemed incomplete because the database had not been updated to reflect the action in time for this report.
  8.  Actions pending and within goal were excluded from the calculation.

APPENDIX A: PDUFA Performance Goals, FY 1998 - FY 2002

 

Performance Goals: FY 98 / FY 99 / FY 00 / FY 01 / FY 02 | NME Goals | Procedural and Processing Goals | Definition of Terms

The following list presents by fiscal year the performance measures set forth in the letters referenced in the Food and Drug Administration Modernization Act of 1997. The following chart lists the goals by fiscal year with appropriate goal measurement dates:

FIVE-YEAR REVIEW PERFORMANCE GOALS

 

Fiscal Year 1998MEASUREMENT DATE
Review and act on 90 percent of standard original NDAs and PLA/BLAs filed during FY 98 within 12 months of receipt1.12 months after end of FY 1998
Review and act on 90 percent of priority original NDAs and PLA/BLAs filed during FY 98 within 6 months of receipt.16 months after end of FY 1998
Review and act on 90 percent of standard efficacy supplements filed during FY 98 within 12 months of receipt.12 months after end of FY 1998
Review and act on 90 percent of priority efficacy supplements filed during FY 98 within 6 months of receipt.6 months after end of FY 1998
Review and act on 90 percent of manufacturing supplements filed during FY 98 within 6 months of receipt.6 months after end of FY 1998
Review and act on 90 percent of resubmitted original applications received during FY 98 within 6 months of receipt, and review and act on 30 percent of Class 1 resubmitted original applications within 2 months of receipt.6 months after end of FY 1998

1The goal letter allows three additional months for review of original NDA, PLA, or BLA submissions that involve major amendments within the last three months of their usual review interval. In these cases, the measurement dates shown in this Appendix move forward by 3 months.

 

 

Fiscal Year 1999MEASUREMENT DATE
1. Review and act on 90 percent of standard original NDAs and PLA/BLAs filed during FY 99 within 12 months of receipt and review and act on 30 percent within 10 months of receipt.1 12 months after end of FY 99
2. Review and act on 90 percent of priority original NDAs and PLA/BLAs filed during FY 99 within 6 months of receipt.16 months after end of FY 99
3. Review and act on 90 percent of standard efficacy supplements filed during FY 99 within 12 months of receipt and review and act on 30 percent within 10 months of receipt.12 months after end of FY 99
 4. Review and act on 90 percent of priority efficacy supplements filed during FY 99 within 6 months of receipt.6 months after end of FY 99
5. Review and act on 90 percent of manufacturing supplements filed during FY 99 within 6 months of receipt and review and act on 30 percent of manufacturing supplements requiring prior approval within 4 months of receipt.6 months after end of FY 99
 6. Review and act on 90 percent of Class 1 resubmitted original applications received during FY 99 within 4 months of receipt, and review and act on 50 percent within 2 months of receipt.4 months after end of FY 99
 7. Review and act on 90 percent of Class 2 resubmitted original applications received during FY 99 within 6 months of receipt.6 months after end of FY 99

1The goal letter allows three additional months for review of original NDA, PLA, or BLA submissions that involve major amendments within the last three months of their usual review interval. In these cases, the measurement dates shown in this Appendix move forward by 3 months.

 

 

 Fiscal Year 2000MEASUREMENT DATE
1. Review and act on 90 percent of standard original NDAs and PLA/BLAs filed during FY 2000 within 12 months of receipt and review and act on 50 percent within 10 months of receipt.112 months after end of FY 2000
 2. Review and act on 90 percent of priority original NDAs and PLA/BLAs filed during FY 2000 within 6 months of receipt.16 months after end of FY 2000
3. Review and act on 90 percent of standard efficacy supplements filed during FY 2000 within 12 months of receipt and review and act on 50 percent within 10 months of receipt.12 months after end of FY 2000
4. Review and act on 90 percent of priority efficacy supplements filed during FY 2000 within 6 months of receipt.6 months after end of FY 2000
5. Review and act on 90 percent of manufacturing supplements filed during FY 2000 within 6 months of receipt and review and act on 50 percent of manufacturing supplements requiring prior approval within 4 months of receipt.6 months after end of FY 2000
6. Review and act on 90 percent of Class 1 resubmitted original applications received during FY 2000 within 4 months of receipt, and review and act on 70 percent within 2 months of receipt.4 months after end of FY 2000
7. Review and act on 90 percent of Class 2 resubmitted original applications received during FY 2000 within 6 months of receipt.6 months after end of FY 2000

1The goal letter allows three additional months for review of original NDA, PLA, or BLA submissions that involve major amendments within the last three months of their usual review interval. In these cases, the measurement dates shown in this Appendix move forward by 3 months.

 

 

 Fiscal Year 2001MEASUREMENT DATE
1. Review and act on 90 percent of standard original NDAs and PLA/BLAs filed during FY 2001 within 12 months of receipt and review and act on 70 percent within 10 months of receipt.112 months after end of FY 2001
2. Review and act on 90 percent of priority original NDAs and PLA/BLAs filed during FY 2001 within 6 months of receipt.16 months after end of FY 2001
3. Review and act on 90 percent of standard efficacy supplements filed during FY 2001 within 12 months of receipt and review and act on 70 percent within 10 months of receipt.12 months after end of FY 2001
4. Review and act on 90 percent of priority efficacy supplements filed during FY 2001 within 6 months of receipt.6 months after end of FY 2001
5. Review and act on 90 percent of manufacturing supplements filed during FY 2001 within 6 months of receipt and review and act on 70 percent of manufacturing supplements requiring prior approval within 4 months of receipt.6 months after end of FY 2001
 6. Review and act on 90 percent of Class 1 resubmitted original applications received during FY 2001 within 2 months of receipt.2 months after end of FY 2001
7. Review and act on 90 percent of Class 2 resubmitted original applications received during FY 2001 within 6 months of receipt.6 months after end of FY 2001

1The goal letter allows three additional months for review of original NDA, PLA, or BLA submissions that involve major amendments within the last three months of their usual review interval. In these cases, the measurement dates shown in this Appendix move forward by 3 months.

 

 

 

 Fiscal Year 2002

MEASUREMENT DATE

1. Review and act on 90 percent of standard original NDAs and PLA/BLAs filed during FY 2002 within 10 months of receipt.110 months after end of FY 2002
2. Review and act on 90 percent of priority original NDAs and PLA/BLAs filed during FY 2002 within 6 months of receipt.16 months after end of FY 2002
3. Review and act on 90 percent of standard efficacy supplements filed during FY 2002 within 10 months of receipt.10 months after end of FY 2002
4. Review and act on 90 percent of priority efficacy supplements filed during FY 2002 within 6 months of receipt.6 months after end of FY 2002
5. Review and act on 90 percent of manufacturing supplements filed during FY 2002 within 6 months of receipt and review and act on 90 percent of manufacturing supplements requiring prior approval within 4 months of receipt.6 months after end of FY 2002
6. Review and act on 90 percent of Class 1 resubmitted original applications received during FY 2002 within 2 months of receipt.2 months after end of FY 2002
7. Review and act on 90 percent of Class 2 resubmitted original applications received during FY 2002 within 6 months of receipt.6 months after end of FY 2002

1The goal letter allows three additional months for review of original NDA, PLA, or BLA submissions that involve major amendments within the last three months of their usual review interval. In these cases, the measurement dates shown in this Appendix move forward by 3 months.

 

NEW MOLECULAR ENTITY (NME) PERFORMANCE GOALS

The performance goals for standard and priority original NMEs will be the same as for all of the original NDAs but will be reported separately.

For biological products, for purposes of this performance goal, all original PLA/BLAs will be considered to be NMEs.

PROCEDURAL AND PROCESSING GOALS

 

Performance AreaAgency ActivityPerformance GoalPerformance Level
Meeting ManagementMeeting Requests -- Notify requester of formal meeting in writing (date, time, place, and participants)within 14 days of receipt of request

FY 1999 requests -- 70% on time

FY 2000 -- 80% on time

FY2001 and on -- 90% on time

Scheduling Meetings -- Schedule meetings within goal date or within 14 days of requested date if longer than goal date.

Type A Meetings within 30 days of receipt of request

 

Type B Meetings within 60 days of receipt of request

 

Type C Meetings within 75 days of receipt of request

 

FY 1999 requests -- 70% on time

FY 2000 -- 80% on time

FY2001 and on -- 90% on time

Meeting Minutes -- Agency prepared minutes, clearly outlining agreements, disagreements, issues for further discussion and action times will be available to sponsorwithin 30 calendar days of meeting

FY 1999 meetings -- 70% on time

FY 2000 -- 80% on time

FY2001 and on -- 90% on time

Clinical HoldsResponse to sponsor's complete response to a clinical holdwithin 30 days of receipt of sponsor's response

FY 1998 -- 75% on time

FY 1999 and on -- 90% on time

Major Dispute ResolutionResponse to sponsor's appeal of decisionwithin 30 days of receipt of sponsor's appeal

FY 1999 -- 70% on time

FY 2000 -- 80 % on time

FY 2001 and on -- 90% on time

Special Protocol Question Assessment and AgreementResponse to sponsor's request for evaluation of protocol designwithin 45 days of receipt of protocol and questions

FY 1999 -- 60% on time

FY 2000 -- 70% on time

FY 2001 -- 80% on time

FY 2002 -- 90% on time

Electronic Applications and SubmissionsPaperless Application ProcessingAgency to develop and update information systems to allow paperless receipt and processing of INDs, human drug applications, and related submissions by end of FY 2002.
Additional ProceduresSimplification of Action LettersCenters to amend regulations and processes to provide for issuance of 'Approval' (AP) or 'Complete Response' (CR) action letters.
Sponsor Notification of Deficiencies in ApplicationsCenters to notify sponsors of deficiencies via 'information request' (IR) when each discipline has finished its initial review.

Definition of Terms:

  1. The term "review and act on" is understood to mean the issuance of a complete action letter after the complete review of a filed complete application. The action letter, if it is not an approval, will set forth in detail the specific deficiencies and, where appropriate, the actions necessary to place the application in condition for approval.
  2. A major amendment to an original application submitted within three months of the goal date extends the goal date by three months. Only one extension is allowed for an application.
  3. A resubmitted original application is a complete response to an action letter addressing all identified deficiencies.
  4. Class 1 resubmitted applications are applications resubmitted after a complete response letter (or a not approvable or approvable letter) that include the following items only (or combinations of these items):
    1. Final printed labeling
    2. Draft labeling
    3. Safety updates submitted in the same format, including tabulations, as the original safety submission with new data and changes highlighted (except when large amounts of new information including important new adverse experiences not previously reported with the product are presented in the resubmission)
    4. Stability updates to support provisional or final dating periods
    5. Commitments to perform Phase 4 studies, including proposals for such studies
    6. Assay validation data
    7. Final release testing on the last 1-2 lots used to support approval
    8. A minor reanalysis of data previously submitted to the application (determined by the agency as fitting the Class 1 category)
    9. Other minor clarifying information (determined by the Agency as fitting the Class 1 category)
    10. Other specific items may be added later as the Agency gains experience with the scheme and will be communicated via guidance documents to industry.
  5. Class 2 resubmissions are resubmissions that include any other items, including any item that would require presentation to an advisory committee.
  6. A Type A Meeting is a meeting that is necessary for an otherwise stalled drug development program to proceed (a "critical path" meeting).
  7. A Type B Meeting is a 1) pre-IND, 2) end of Phase 1 (for Subpart E or Subpart H or similar products) or end of Phase 2/pre-Phase 3, or 3) a pre- NDA/PLA/BLA meeting. Each requester should usually only request 1 each of these Type B meetings for each potential application (NDA/PLA/BLA) (or combination of closely related products, i.e., same active ingredient but different dosage forms being developed concurrently).
  8. A Type C Meeting is any other type of meeting.

APPENDIX B: List of Approved Applications

 

Approved Priority NDAs/BLAs | Approved Standard NDAs/BLAs | Terms and Coding

Tables(Priority and Standard NDA/BLA Approvals by Fiscal Year):
FY 2001 Priority | FY 2001 Standard | FY 2000 Priority | FY 2000 Standard | FY 1999 and Earlier Priority | FY 1999 and Earlier Standard

This appendix updates the detailed review histories of the NDAs and PLA/BLAs submitted and approved under PDUFA. It shows approvals of all PDUFA-related submissions that took place in FY 02 as well as FY 01 approvals of FY 01 submissions. Earlier PDUFA approvals were listed in previous performance reports.

The following two tables summarize the review histories for all approved applications submitted from FY 96 through FY 01. The tables show the average first review, second review, and approval times. Note that times are in months, not all applications required a second review, and some required more than two reviews. The mean total approval times shown in the tables will increase in the future as additional applications are approved.

Approved Priority NDAs/BLAs

 1st Review2nd Review

Total

Approval Time

Receipt CohortNFDA ReviewnFDA Review
FY96337.6156.94.015.2
FY97236.3104.43.69.5
FY98316.1121.52.78.3
FY99256.371.62.17.3
FY00236.083.94.39.5
FY0186.661.53.711.5

 

Approved Standard NDAs/BLAs

 

 1st Review2nd Review

Total

Approval Time

Receipt CohortnFDA ReviewnFDA Review
FY967411.9414.34.017.9
FY978411.6376.33.916.4
FY986411.4405.44.818.9
FY996810.7313.63.915.5
FY006310.5324.03.815.0
FY013010.7122.43.213.1

 

 

The remainder of this appendix shows the individual review histories. Approvals are grouped by submission year and priority designation and listed in order of total approval time. Review histories of all other PDUFA submissions approved prior to FY 02 can be found in the appendices of the earlier PDUFA Performance Reports which are available on FDA's web site (FDA Home)

Terms and Coding Used In Tables

 

(+) FY 01 approval of a FY 01 submission. These were not included in earlier PDUFA performance reports and are included here for completeness.
(**) Major amendment was received within 3 months of the action due date, which extended the review timeframes by 3 months.
Action Codes:

AE = Approvable

AP = Approved

NA = Not Approvable

RL = Complete Response

WD = Withdrawn

 

Table 1
FY 2001 Priority NDA and BLA Submissions Approved in FY 01 (+) and FY 02

 

 Generic NameSponsorApproval Time (Months)
Total Time

Approval Time (Months)
Resubmissions

(if necessary)

Review Goal Met

+

IMATINIB MESYLATENovartis Farms2.4 Y
 TENOFOVIR DISOPROXIL FUMARATEGilead5.9 Y
 BUDESONIDEAstraZeneca8.3FDA First Action: 6.0 (AE)
Sponsor Response: 0.3
FDA Second Action: 2.0 (AP)

Y

 

Y

 FONDAPARINUX SODIUMFonda BV9.7FDA First Action: 6.0 (AE)
Sponsor Response: 1.8
FDA Second Action: 1.9 (AP)

Y

 

Y

 DROTRECOGIN ALFA (ACTIVATED) (BLA)Eli Lilly & Company9.8FDA First Action: 9.0 (RL)
Sponsor Response: 0.4
FDA Second Action: 0.5 (AP)

Y**

Y

 IBRITUMOMAB TIUXETAN (BLA)IDEC Pharmaceuticals Corporation15.6FDA First Action: 6.0 (RL)
Sponsor Response: 2.2
FDA Second Action: 6.0 (RL)
Sponsor Response: 1.3
FDA Third Action: 0.0 (AP)

Y

Y

Y

 TREPROSTINIL SODIUMUnited Therap19.1FDA First Action: 8.6 (WD)
Sponsor Response: 1.2
FDA Second Action: 6.0 (AE)
Sponsor Response: 1.7
FDA Third Action: 1.6 (AP)

Y**

Y

Y

 SODIUM OXYBATEOrphan Medical21.5FDA First Action: 9.0 (AE)
Sponsor Response: 3.3
FDA Second Action: 6.0 (AE)
Sponsor Response: 1.2
FDA Third Action: 2.0 (AP)

Y**

Y

Y

Table 2
FY 2001 Standard NDA and BLA Submissions Approved in FY 01 (+) and FY 02

 

 Generic NameSponsorApproval Time (Months)
Total Time

Approval Time (Months)
Resubmissions

(if necessary)

Review Goal Met
 LEUPROLIDE ACETATE (INJECTION) 22.5MGAtrix Labs9.9 Y
 MONTELUKAST SODIUMMerck Research Labs9.9 Y
 AZITHROMYCIN DIHYDRATEPfizer9.9 Y
 PEGFILGRASTIM (BLA)Amgen, Inc.10.0 Y
 ASPIRINBayer Cons10.0 Y
 VALDECOXIBGD Searle LLC10.0 Y
 LEVOTHYROXINE SODIUMMova Pharms10.0 Y
 IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE (ORAL SUSPENSION)Wyeth Cons10.0 Y
 IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE (CAPSULE)Wyeth Cons10.0 Y
 EFAVIRENZBristol Myers Squibb10.0 Y
 LEUPROLIDE ACETATE (INJECTION) 7.5MGAtrix Labs10.0 Y
 NORELGESTROMIN; ETHINYL ESTRADIOLOrtho Mcneil Pharm11.0 Y
 DUTASTERIDEGlaxoSmithKline11.0 Y
 ERTAPENEM SODIUMMerck11.7 Y
 LEVOTHYROXINE SODIUMAbbott Labs11.7 Y
 PIMECROLIMUSNovartis Pharms11.9 Y
 BOSENTANActelion12.1FDA First Action: 10.0 (AE)
Sponsor Response: 1.0
FDA Second Action: 1.2 (AP)

Y

 

Y

 MIXED SALT OF SINGLE ENTITY AMPHETAMINEShire Labs12.3FDA First Action: 10.0 (AE)
Sponsor Response: 0.4
FDA Second Action: 1.9 (AP)

Y

 

Y

 DEXMETHYLPHENIDATE HYDROCHLORIDENovartis Pharms12.6FDA First Action: 9.9 (AE)
Sponsor Response: 0.8
FDA Second Action: 2.0 (AP)
Y
 MOXIFLOXACIN HYDROCHLORIDEBayer12.9 Y**
 FULVESTRANTAstraZeneca12.9 Y **
 ESTRADIOLWatson Labs10.1FDA First Action: 10.0 (AE)
Sponsor Response: 0.1
FDA Second Action: 1.9 (AE)
Sponsor Response: 0.6
FDA Third Action 1.9 (AP)

Y

 

Y

 

Y

 LOVASTATINAndrx14.9FDA First Action: 10.0 (AE)
Sponsor Response: 0.7
FDA Second Action: 1.9 (AE)
Sponsor Response: 0.5
FDA Third Action 1.8 (AP)

Y

 

Y

 

Y

 ESCITALOPRAM OXALATEForest Labs16.7FDA First Action: 10.0 (AE)
Sponsor Response: 1.0
FDA Third Action 5.7 (AP)

Y

 

Y

 DESLORATADINE (ORALLY DISINTEGRATING TABLET)Schering18.1FDA First Action: 9.9 (AE)
Sponsor Response: 2.2
FDA Second Action: 6.0 (AP)

Y

Y

 VORICONAZOLE (TABLET)Pfizer18.2FDA First Action: 13.0 (AE)
Sponsor Response: 3.3
FDA Second Action: 1.9 (AP)

Y

Y

 VORICONAZOLE (INJECTION)Pfizer18.2FDA First Action: 13.0 (AE)
Sponsor Response: 3.3
FDA Second Action: 1.9 (AP)

Y

Y

 METHYLPHENIDATE HYDROCHLORIDENovartis Pharms18.2FDA First Response: 10.1 (AE)
Sponsor Response: 2.2
FDA Second Action: 5.9 (AP)

Y

Y

 AMOXICILLIN, CLAVULANATE POTASSIUMGlaxoSmithKline21.2FDA First Response: 11.7 (NA)
Sponsor Response: 3.5
FDA Second Action: 5.9 (AP)

Y

Y

 DESMOPRESSIN ACETATEFerring Pharms22.4FDA First Action: 9.8 (AE)
Sponsor Response: 10.6
FDA Second Action: 2.0 (AP)

Y

Y

Table 3
FY 2000 Priority NDA and BLA Submissions Approved in FY 02

 Generic NameSponsorApproval Time (Months)
Total Time

Approval Time (Months)
Resubmissions

(if necessary)

Review Goal Met
 NITISINONESwedish Orphan16.3FDA First Action: 7.8 (AE)
Sponsor Response: 2.6
FDA Second Action: 6.0 (AP)

N

Y

 ATROPINE; PRALIDOXIME CHLORIDEUS Army25.4FDA First Action: 6.0 (AE)
Sponsor Response: 14.3
FDA Second Action: 5.1 (AP)

Y

Y

 TEGASEROD MALEATENovartis Pharms29.4FDA First Action: 6.0 (AE)
Sponsor Response: 4.2
FDA Second Action: 5.9 (NA)
Sponsor Response: 8.5
FDA Third Action: 4.8 (AP)

Y

Y

Y

Table 4
FY 2000 Standard NDA and BLA Submissions Approved in FY 02

 Generic NameSponsorApproval Time (Months)
Total Time

Approval Time (Months)
Resubmissions

(if necessary)

Review Goal Met
 NIACIN; LOVASTATINKos Pharms13.81FDA First Action: 9.9 (AE)
Sponsor Response: 1.9
FDA Second Action: 2.0 (TA)

Y

Y

 EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDEUnimed Pharms14.1FDA First Action: 9.9 (AE)
Sponsor Response: 3.2
FDA Second Action: 1.0 (AP)

Y

Y

 UROFOLLITROPINFerring Pharms19.2FDA First Action: 9.9 (NA)
Sponsor Response: 3.4
FDA Second Action: 6.0 (AP)

Y

Y

 PAROXETINE HYDROCHLORIDESynthon Pharms19.52FDA First Action: 10.0 (AE)
Sponsor Response: 3.9
FDA Second Action: 5.7 (TA)

Y

Y

 OLMESARTAN MEDOXOMILSankyo Pharma Inc21.0FDA First Action: 15.0 (AE)
Sponsor Response: 5.5
FDA Second Action: 0.6 (AP)

Y**

Y

 ETONOGESTREL; ETHINYL ESTRADIOLOrganon Inc21.2FDA First Action: 111.8 (AE)
Sponsor Response: 2.3
FDA Second Action: 1.9 (AE)
Sponsor Response: 3.2
FDA Third Action: 2.0 (AP)

Y

Y

Y

 MORPHINE SULFATEElan Pharm21.7FDA First Action: 10.0 (AE)
Sponsor Response: 5.7
FDA Second Action: 6.0 (AP)

Y

Y

 HEP B IMMUNE GLOBULIN (HUMAN) (BLA)Nabi22.2FDA First Action: 8.5 (RL)
Sponsor Response: 4.7
FDA Second Response 9.0 (AP)

Y

N

 INSULIN ASPART 30UNIT/ML; INSULIN ASPART PROTAMINE 70UNIT/MLNovo Nordisk Pharm22.4FDA First Action: 10.8 (AE)
Sponsor Response: 5.5
FDA Second Action: 6.0 (AP)

Y

Y

 ANAKINRA (BLA)Amgen, Inc.22.6FDA First Action: 10.7 (RL)
Sponsor Response: 3.5
FDA Second Action: 6.0 (RL)
Sponsor Response: 0.4
FDA Third Action: 2.0 (AP)

Y

Y

Y

 LEVOTHYROXINE SODIUMGenpharm22.8FDA First Action: 9.9 (AE)
Sponsor Response: 7.0
FDA Second Action: 5.9 (AP)

Y

Y

 NORGESTIMATE; ETHINYL ESTRADIOLJohnson and Johnson23.9FDA First Action: 10.0 (AE)
Sponsor Response: 12.0
FDA Second Action: 1.9 (AP)

Y

Y

 GUAIFENESINAdams Labs24.4FDA First Action: 9.9 (AE)
Sponsor Response: 2.0
FDA Second Action: 5.8 (AE)
Sponsor Response: 0.8
FDA Third Response: 5.9Adams Labs (AP)

Y

Y

Y

 DESLORATADINE (TABLET)Schering26.0FDA First Action: 15.0 (AE)
Sponsor Response: 10.5
FDA Second Action: 0.5 (AP)

Y**

Y

 ALPROSTADILPharmacia and Upjohn28.7FDA First Action: 10.0 (AE)
Sponsor Response: 12.7
FDA Second Action: 6.0 (AP)

Y

Y

 RASBURICASE (BLA)Sanofi-Synthelabo, Inc.30.9FDA First Action: 10.7 (RL)
Sponsor Response: 3.7
FDA Second Action: 6.0 (RL)
Sponsor Response: 4.3
FDA Third Action: 6.0 (AP)

Y

Y

Y

 PERFLEXANE LIPID MICROPHERESAlliance Pharm31.6FDA First Action: 10.0 (AE)
Sponsor Response: 12.2
FDA Second Action: 5.6 (AE)
Sponsor Response: 2.0
FDA Third Action: 1.7 (AP)

Y

Y

Y

1This application received tentative approval on 11/16/01. This date was used to calculate the total approval time. The application received final approval on 12/17/02.

2This application received tentative approval on 3/11/02. This date was used to calculate the total approval time. 

 

Table 5
FY 1999 and Earlier Priority NDA and BLA Submissions Approved in FY 02

 

Receipt CohortGeneric NameSponsor

Approval Time (Months)

Total Time

Approval Time (Months)

Resubmissions

(if necessary)

Review Goal Met
FY 1996DIPTHERIA & TETANUS TOXOIDS & ACELLULAR PERTUSSIS VACCINE ADSORBED (BLA)Aventis Pasteur Limited71.5FDA First Action: 12.0 (NA)
Sponsor Response: 27.8
FDA Second Action: 6.0 (RL)
Sponsor Response: 4.4
FDA Third Action: 6.0 (RL)
Sponsor Response: 11.8
FDA Fourth Action: 3.6 (AP)

Y

Y

Y

Y



 

Table 6
FY 1999 and Earlier Standard NDA and BLA Submissions Approved in FY 02

Receipt CohortGeneric NameSponsor

Approval Time (Months)

Total Time

Approval Time (Months)

Resubmissions

(if necessary)

Review Goal Met
FY 1999FROVATRIPTAN SUCCINATEElan Pharms21.03FDA First Action: 15.0 (AE)
Sponsor Response: 12.3
FDA Second Action: 6.0 (AP)

Y**

Y

FY 1999FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOINHill Dermaceuticals34.0FDA First Action: 10.0 (AE)
Sponsor Response: 1.5
FDA Second Action: 6.0 (AE)
Sponsor Response: 11.0
FDA Third Action: 5.8 (AP)

Y

Y

Y

FY 1999SECRETIN PORCINE SYNTHETICChiRhoClin34.4FDA First Action: 9.5 (AE)
Sponsor Response: 1.5
FDA Second Action: 6.0 (AE)
Sponsor Response: 11.0
FDA Third Action: 5.8 (AP)

Y

Y

Y

FY 1999PAMIDRONATE DISODIUMBedford Labs36.1FDA First Action: 9.5 (AE)
Sponsor Response: 2.5
FDA Second Action: 6.0 (AE)
Sponsor Response: 2.5
FDA Third Action: 6.0 (AE)
Sponsor Response: .6
FDA Fourth Action: 5.9 (AP)

Y

Y

Y

Y

FY 1998INTERFERON BETA-1A (BLA)Serono, Inc.48.4FDA First Action: 12.0 (RL)
Sponsor Response: 3.6
FDA Second Action: 6.0 (RL)
Sponsor Response: 2.3
FDA Third Action: 2.0 (RL)
Sponsor Response: 6.3
FDA Fourth Action: 2.0 (RL)
Sponsor Response: 8.0
FDA Fifth Action: 6.0 (AP)

Y

Y

Y

Y

Y

FY 1998ZIPRASIDONE MESYLATEPfizer54.1FDA First Action: 12.0 (NA)
Sponsor Response: 20.7
FDA Second Action: 5.9 (AE)
Sponsor Response: 9.5
FDA Third Action: 6.0 (AP)

Y

Y

Y

FY 1997MESNABristol Myers Squibb59.9FDA First Action: 12.0 (NA)
Sponsor Response: 42.0
FDA Second Action: 6.0 (AP)

Y

Y

FY 1996CLINDAMYCIN PHOSPHATE; BENZOYL PEROXIDEStiefel Labs75.5FDA First Action: 12.0 (NA)
Sponsor Response: 8.6
FDA Second Action: 0.0 (NA)
Sponsor Response: 25.2
FDA Third Action: 6.0 (NA)
Sponsor Response: 17.7
FDA Third Action: 6.0 (AP)

Y

Y

Y

Y

3 Total approval time for this NDA was adjusted. Initial animal studies did not adequately meet the standards for characterizing the carcinogenic potential of frovatriptan succinate. The time period from 4/28/00 to 5/08/01 was excluded from the total approval time while the firm performed the additional carcinogenic potential animal studies.