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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RFDs Withdrawn by Sponsor |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
|
3 total:
|
6 total:
7 total: |
9
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 31 original RFD decisions. Three requests for reconsideration responded to within 15 day timeframe required by 21 CFR 3.8(c).