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|
Combination |
Non-Combination |
Total |
Pending Beginning of Period |
1 |
2 |
3 |
Original RFDs Submitted* |
32 |
23 |
55 |
Requests
for Reconsideration Submitted |
1† |
2‡ |
3 |
Total |
34 |
27 |
61
|
Original
RFD Decisions Issued |
26 |
15 |
41 |
Responses
to Requests for Reconsideration Issued |
1 |
1 |
2 |
RFD’s
Withdrawn During Period |
3 |
2 |
5 |
Pending
at End of Period: Not overdue Overdue Reconsiderations |
0 0 |
0 1 |
0 1 |
Total |
34 |
27 |
61 |
Assignments CBER
|
2 device/biologic
5 drug/device
15 drug/device
†
|
1 device
4 drug
11
device |
|
Total |
26 |
17 |
43 |
Mean Total Review Time§ |
38.3 days |
44.8 days |
40.7 |
Median Total Review Time§ |
35 days |
45 days |
41.0 |
Range of Total Review Time§ |
18-59 days |
31-59 days |
18-59 |
* Nine original RFDs received were not filed due to insufficient
information.
†One original decision changed from combination
product to non-combination product assigned to CDRH
‡One
original decision confirmed
§
Based on 41 original RFD decisions.
Two requests for reconsideration responded to within 15 day timeframe required
by 21 CFR 3.8(c)