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FY07 OCP Review Performance:

Formal Requests for Designation Submitted by Industry

October 1, 2006 – September 30, 2007

 

RFDs Pending Beginning of Period

6

Original RFDs Submitted

77

Requests for Reconsideration Submitted

  6

 RFDs Withdrawn by Sponsor

 3

  RFDs Not Filed (Incomplete)

18

Pending at End of Period (Not Overdue)

10

                      Total Decisions Issued*

52

 

DECISIONS ISSUED

Combination Products

Non-Combination Products

Total

CBER

 

 



CDER

 

 

 

CDRH

 

3 total:
3 device/biologic

 

 


13 total:
1 drug/biologic
7 drug/device
2 drug/device/biologic
3 drug/device reconsideration



20 total:
19 drug/device
1 drug/device reconsideration
  

6 total:
2 biologic and tissue
3 device
1 drug

 


8 total:
7 drug
1 drug reconsideration

 

 

7 total:
7 device

 9

 

 


21

 

 

 

27

RFD Decisions Issued

32

20

52

Responses to Requests for Reconsideration Issued

 4

1

  5

Total

36

21

57

Mean Total Review Time

35.4 days

41.6 days

37.9

Median Total Review Time

32 days

43 days

36

Range of Total Review Time

12-60 days

18-60 days

12-60

Based on 31 original RFD decisions.  Three requests for reconsideration responded to within 15 day timeframe required by 21 CFR 3.8(c).

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