Efficacy Supplements

Goal -- Review and act upon complete efficacy supplements to NDAs and BLAs5

On-time Goal
Submission Year
FY 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):
FY 95
FY 96
FY 97
FY 98
FY 996
  • to NDAs  
77
103
146 (10/136)
128 (9/119)
138 (16/122)
  • to BLAs  
10
8
15 (3/12)
10 (1/9)
9 (2/7)
  • PDUFA total  
87
111
161 (13/148)
138 (10/128)
147 (18/129)
Performance 
FY 98 Submissions:
  • 8 of 10 priority efficacy supplements were reviewed and acted upon on time. Combined CDER/CBER performance was 80 percent on time. 
  • All but one of the 128 standard efficacy supplements have been reviewed and acted upon, all on time. The one that has not been reviewed is overdue. Combined CDER/CBER performance was 99 percent on time. 
FY 99 Submissions:
  • As of September 30, 1999, 7 priority and 22 standard FY 99 efficacy supplements had been reviewed and acted upon. All the standard supplements and 6 of the priorities were on time.
  • Combined CDER/CBER early-indicator performance for 7 priority efficacy supplements (6-month goal) received during the first six months of FY 99 is 86 percent on time. 


 
Manufacturing Supplements

Goal -- Review and act upon complete manufacturing supplements to NDAs and BLAs5

On-time Goal
Submission Year
FY 98
FY 99
FY 00
FY 01
FY 02
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 (Total/Prior App): 
FY 95
FY 96
FY 97
FY 98
FY 996
  • to NDAs  
1,249
1,218
1,262
1,463
1,468 (994)
  • to BLAs  
273
261
338
371
390 (251)
  • PDUFA total  
1,522
1,479
1,600
1,834
1,858 (1,245)

Performance:

FY 98 Submissions:
  • All 1,834 FY 98 manufacturing supplements have been reviewed and acted upon, 1,807 on time. 
  • Combined CDER/CBER on-time performance was 99 percent. 
FY 99 Submissions:
  • 1,148 FY 99 manufacturing supplements have been reviewed and acted upon; 758 were prior approval supplements. 
  • 99 percent of all manufacturing supplements reviewed and acted upon were within the 6 month goal and 80 percent of the prior approval supplements reviewed and acted upon were within the 4 month goal. 
  • Early indicator performance on all 864 manufacturing supplements received in the first 6 months of FY 99 is 99 percent on time. 
  • Early indicator performance on the 720 prior approval supplements (4 month goal) received in the first 8 months of FY 99 is 78 percent on time. 

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