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U.S. Department of Health and Human Services

Combination Products

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Fiscal Year 2009

FY 2009 OCP Review Performance:

Formal Requests for Designation Submitted by Industry

October 1, 2008 – September 30, 2009

 

RFDs Pending Beginning of Period5
Original RFDs Submitted51
Requests for Reconsideration Submitted4
RFDs Withdrawn by Sponsor10
RFDs Not Filed (Incomplete)25
Pending at End of Period (Not Overdue)7
Total Decisions Issued*18

 

 

DECISIONS ISSUED

Combination Products

Non-Combination Products

Total

CBER

1 total:

1 device/biologic

2 total:
1 biologic and tissue

1 device

3
CDER

8 total:

6 drug/device

2 drug/device reconsiderations

4 total:
3 drug

1 drug reconsideration

12
CDRH

3 total:
2 drug/device

1 drug/device reconsideration

0 total:
 
3
RFD Decisions Issued9514
Responses to Requests for Reconsideration Issued314
Total12618
Mean Total Review Time52.2 days46.4 days50.1
Median Total Review Time56 days51 days55.5
Rangeof Total Review Time27-60 days24-59 days24-60

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