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U.S. Department of Health and Human Services

Combination Products

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Fiscal Year 2007

FY 2007 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RFDs Withdrawn by Sponsor 3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 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