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U.S. Department of Health and Human Services

Combination Products

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Fiscal Year 2008

FY 2008 OCP Review Performance:

Formal Requests for Designation Submitted by Industry

October 1, 2007 – September 30, 2008

 

RFDs Pending Beginning of Period 10
Original RFDs Submitted 86
Requests for Reconsideration Submitted 4
RFDs Withdrawn by Sponsor 6
RFDs Not Filed (Incomplete) 46
Pending at End of Period (Not Overdue) 5
Total Decisions Issued* 43

 

 

DECISIONS ISSUED

Combination Products

Non-Combination Products

Total

CBER

2 total:

2 device/biologic

7 total:
6 biologic and tissue

1 drug/biologic reconsideration

9
CDER

15 total:

1 drug/biologic

13 drug/device

1 drug/device reconsideration

10 total:
8 drug

2 drug reconsiderations

25
CDRH 6 total:
6 drug/device
3 total:
3 device
9
RFD Decisions Issued 22 17 39
Responses to Requests for Reconsideration Issued 1 3 4
Total 23 20 43
Mean Total Review Time 57.4 days 56.2 days 56.9
Median Total Review Time 59 days 58 days 58
Rangeof Total Review Time 36-60 days 28-60 days 28-60

Based on original RFD decisions. Requests for Reconsideration are responded to within a 15 day timeframe as required by 21 CFR 3.8(c).

*Includes Original RFDs and Requests for Reconsideration