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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RFDs Withdrawn by Sponsor	6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

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