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U.S. Department of Health and Human Services

Combination Products

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Fiscal Year 2010

FY 2010 OCP Review Performance:

Formal Requests for Designation Submitted by Industry

October 1, 2009 – September 30, 2010

 

RFDs Pending Beginning of Period7
Original RFDs Submitted89
Requests for Reconsideration Submitted8
RFDs Withdrawn by Sponsor3
RFDs Not Filed (Incomplete)44
Pending at End of Period (Not Overdue)5
Total Decisions Issued*52

 

 

DECISIONS ISSUED

Combination Products

Non-Combination Products

Total

CBER

3 total:

2 drug/biologic

1 drug/device/biologic

3 total:
3 biologic and tissue

6
CDER

25 total:

17 drug/device

2 drug/biologic

1 device/biologic

1 drug/device/biologic

drug/device reconsiderations

1 device/biologic reconsideration

11 total:

7 drug

drug reconsideration

36
CDRH

8 total:

6 drug/device

2 device/biologic

2 total:
 

2 device

10
RFD Decisions Issued321244
Responses to Requests for Reconsideration Issued448
Total361652
Mean Total Review Time53.4 days57.8 days54.6 days
Median Total Review Time58 days60 days58.5 days
Rangeof Total Review Time21-60 days48-60 days21-60 days

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