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Combination Products
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Fiscal Year 2007
FY 2007 OCP Review Performance:
Formal Requests for Designation Submitted by Industry
October 1, 2006 – September 30, 2007
| RFDs Pending Beginning of Period | 6 |
| Original RFDs Submitted | 77 |
| Requests for Reconsideration Submitted | 6 |
| RFDs Withdrawn by Sponsor | 3 |
| RFDs Not Filed (Incomplete) | 18 |
| Pending at End of Period (Not Overdue) | 10 |
| Total Decisions Issued* | 52 |
DECISIONS ISSUED |
Combination Products |
Non-Combination Products |
Total |
|---|---|---|---|
| CBER CDER CDRH |
3 total: 3 device/biologic 13 total: 1 drug/biologic 7 drug/device 2 drug/device/biologic 3 drug/device reconsideration 20 total: 19 drug/device 1 drug/device reconsideration |
6 total: 2 biologic and tissue 3 device 1 drug 8 total: 7 drug 1 drug reconsideration 7 total: 7 device |
9 21 27 |
| RFD Decisions Issued | 32 | 20 | 52 |
| Responses to Requests for Reconsideration Issued | 4 | 1 | 5 |
| Total | 36 | 21 | 57 |
| Mean Total Review Time† | 35.4 days | 41.6 days | 37.9 |
| Median Total Review Time† | 32 days | 43 days | 36 |
| Range of Total Review Time† | 12-60 days | 18-60 days | 12-60 |
†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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