Efficacy Supplements
 

  

 
 

 Goal -- Review and act upon complete efficacy supplements to NDAs and BLAs 
 
On-time Goal
Submission Year
FY 978-98
FY 99
FY 00
FY 01
FY 02
Priority 
 6 months
90%
90
90
90
90
Standard
 12 months
10 months
90%
 
90
30
90
50
90
70
 
90
 
 
Workload -- Efficacy supplements filed (Priority / Standard):
FY94
FY95
FY96
FY97
FY98
  • to NDAs
    		•
    86
    77
    106
    147(10/137)
    122(6/116)
  • to BLAs
    		•
    6
    10
    8
    15 (3/12)
    10 (1/9)
  • PDUFA total
    		•
    92
    87
    114
    162(13/149)
    132(7/125)
     

    Performance 
     

      FY 97 Submissions:   
    • All 162 FY 97 efficacy supplements have been reviewed, 160 on time.
    • All priority efficacy supplements were reviewed on time.
    • Combined CDER/CBER on-time performance was 99 percent.  

      • FY 98 Submissions:   
       

    • As of September 30, 1998, 2 priority and 21 standard FY 98 efficacy supplements had been reviewed, all on time.
    • Combined CDER/CBER early-indicator performance for 2 priority efficacy supplements (6-month goal) received during the first six months of FY 98 is 100 percent on time.

     
     
    Manufacturing Supplements
     

     
     

    		Goal -- Review and act upon complete manufacturing supplements to NDAs and BLAs 
      
     
    On-time Goal
    Submission Year
    FY978,98
    FY99
    FY00
    FY01
    FY02
    Prior approval not required
    6 months
    90%
    90
    90
    90
    90
    Prior approval required
    6 months
    4 months
    90%
     
    90
    30
    90
    50
    90
    70
    90
      
     
    Workload -- Manufacturing supplements filed: 
    FY94
    FY95
    FY96
    FY97
    FY984
  • to NDAs
    		•
    871
    1,249
    1,218
    1,262
    1,460
  • to BLAs
    		•
    186
    273
    261
    338
    370
  • PDUFA total
    		•
    1,057
    1,522
    1,479
    1,600
    1,830
    Performance: 
     
      FY 97 Submissions: 
    • All 1,600 FY 97 manufacturing supplements have been reviewed, 1,577 on time.
    • Combined CDER/CBER on-time performance was 99 percent.

      • FY 98 Submissions:   
       

    • As of September 30, 1998, 1,157 FY 98 manufacturing supplements had been reviewed, 1,146 on time.
    • Combined CDER/CBER early-indicator performance for 914 manufacturing supplements received during the first six months of FY 98 is 98 percent on time.
     
     


     
    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 more detailed description of the goals, the annual performance targets, and definitions of terms can be found in Appendix C. With the exception of the "clinical holds" goal, none of these goals had performance targets for FY 98. 

    Meeting Management: 

    • Meeting Requests:
    • Scheduling Meetings:
    • Meeting Minutes:
    Clinical Holds: 

    Respond to sponsor's complete response to a clinical hold within 30 days of receipt 
    Submission Year
    FY989
    FY99
    FY00
    FY01
    FY02
    On-time Goal
    75%
    90
    90
    90
    90
    Sponsor's Complete Responses
    42
    		        
    FDA Actions
    Within Goal
    34
    		        
    Overdue
    8
    		        
    % On time
    81%
    		        

    Major Dispute Resolution: 

    Special Protocol Question Assessment and Agreement: 

    Electronic Applications and Submissions: 

    Simplification of Action Letters: 

    Sponsor Notification of Deficiencies in Applications: 
     



    Notes:

    1.  This report uses the terms PDUFA I and PDUFA II to distinguish between the original Prescription Drug User Fee Act of 1992 and the Act as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA) respectively.  Where no distinction is needed or where the reference is obvious, the term PDUFA is used.

     2.  Source: United States General Accounting Office, FDA Drug Approval: Review Time Has Decreased in Recent Years (GAO/PEMD-96-1), October 1995

    3.  Although the last approvals for FY 97 submissions (as well as for earlier years) have not yet occurred, the median statistic can be computed from approvals to date and estimates of the percent of submissions that will ultimately be approved.

    4.  CBER's workload counts and performance statistics in PDUFA I Performance Reports included original and resubmitted ELAs.  CBER is in the process of changing from counting PLAs and ELAs separately to combining them as BLAs (Biologic License Applications).   This report shows CBER's workload and performance on PLAs and BLAs only (i.e., Product Applications) and, for notational simplicity, refers to both as BLAs.  Original and resubmitted ELAs have been dropped, both from workload counts and performance measurements.

    5.  The count of FY 98 submissions assumes that all submissions received in the last two months of FY 98 are filed.  When FDA files a submission, it is deemed ìcompleteî 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.

    6.  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 re-designated as non-NMEs.  In FY 98, CDER designated 53 filings as NMEs initially (21 priority, 32 standard).  Only 47 of these are "discrete" (18 priority, 29 standard).

    7.  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 its original application's year.  This explains the relatively low number of resubmissions in the early PDUFA years.

    8.  Performance goals for supplements submitted from FY 93 to FY 2002 were written in terms of Efficacy Supplements and Manufacturing Supplements except for FY 97.  The goals for FY 97 were written in terms of priority supplements (which had 6-month goals), standard supplements with clinical data (12-months), and standard supplements without clinical data (6-months).  Since some efficacy supplements do not contain clinical data and some manufacturing supplements contain clinical data, FY 97 supplement performance, if strictly interpreted, does not correspond exactly with any other PDUFA years.  The statistics in the body of this report ignore this anomaly and measure FY 97 supplement performance in terms of efficacy supplements (priority and standard) and manufacturing supplements.  Here, however, are the strictly interpreted performance figures for FY 97:

    9.  FDA did not begin tracking performance on responses to clinical holds until March 1, 1998.
     
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