FY04 OCP Review Performance:

Combination
Products

Non-Combination
Products

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RFD’s Withdrawn During Period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

4

0

0

8

0

1

12

0

1

Total

34

27

61

Assignments

CBER

CDER

CDRH

3 total:

2 device/biologic
1 drug/device/biologic

6 total:

5 drug/device
1 device/biologic

17 total:

15 drug/device ^†
  2 device/biologic

2 total:

1 device
1 biologic

4 total:

4 drug
 [3 original;
  1 reconsideration]

11 total:

          11 device
         [10 original;
           1 reconsideration]

5

10

28

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