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 Period | 5 |
| Original RFDs Submitted | 51 |
| Requests for Reconsideration Submitted | 4 |
| RFDs Withdrawn by Sponsor | 10 |
| 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 device | 3 |
| CDER | 8 total: 6 drug/device 2 drug/device reconsiderations | 4 total: 1 drug reconsideration | 12 |
| CDRH | 3 total: 1 drug/device reconsideration | 0 total: | 3 |
| RFD Decisions Issued | 9 | 5 | 14 |
| Responses to Requests for Reconsideration Issued | 3 | 1 | 4 |
| Total | 12 | 6 | 18 |
| Mean Total Review Time† | 52.2 days | 46.4 days | 50.1 |
| Median Total Review Time† | 56 days | 51 days | 55.5 |
| Rangeof Total Review Time† | 27-60 days | 24-59 days | 24-60 |
†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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