Combination Products
-
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 Period | 7 |
Original RFDs Submitted | 89 |
Requests for Reconsideration Submitted | 8 |
RFDs Withdrawn by Sponsor | 3 |
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: | 6 |
CDER | 25 total: 17 drug/device 2 drug/biologic 1 device/biologic 1 drug/device/biologic 3 drug/device reconsiderations 1 device/biologic reconsideration | 11 total: 7 drug 4 drug reconsideration | 36 |
CDRH | 8 total: 6 drug/device 2 device/biologic | 2 total: 2 device | 10 |
RFD Decisions Issued | 32 | 12 | 44 |
Responses to Requests for Reconsideration Issued | 4 | 4 | 8 |
Total | 36 | 16 | 52 |
Mean Total Review Time† | 53.4 days | 57.8 days | 54.6 days |
Median Total Review Time† | 58 days | 60 days | 58.5 days |
Rangeof Total Review Time† | 21-60 days | 48-60 days | 21-60 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
-
-