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U.S. Department of Health and Human Services

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Number of Approvals in the month

Dictionary: The straightforward number of applications approved is a high level measure of the overall performance of OGD. However, it does not reflect all review work accomplished, such as the time invested reviewing applications that are not approvable.


These measures have been retired as CDER has created new measures for FY13 which align to their four functional areas of 1) Regulatory Review and Drug Safety, 2) Drug Quality and Compliance, 3) Transparency and Public Outreach, and 4) Regulatory Science Research.

Fiscal Year - 2010

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TimeTargetNumber
Oct 2009N/A25
Nov 2009N/A43
Dec 2009N/A31
Jan 2010N/A18
Feb 2010N/A26
Mar 2010N/A28
Apr 2010N/A46
May 2010N/A44
Jun 2010N/A64
Jul 2010N/A42
Aug 2010N/A30
Sep 2010N/A29

FY 2010 Total: 426

Number of Tentative Approvals in the month

Dictionary: The straightforward number of applications tentatively approved is a high level measure of the overall performance of OGD. However, it does not reflect all review work accomplished, such as the time invested reviewing applications that are not approvable.

Fiscal Year - 2010

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TimeTargetNumber
Oct 2009N/A8
Nov 2009N/A9
Dec 2009N/A15
Jan 2010N/A19
Feb 2010N/A4
Mar 2010N/A9
Apr 2010N/A17
May 2010N/A19
Jun 2010N/A12
Jul 2010N/A8
Aug 2010N/A11
Sep 2010N/A11

FY 2010 Total: 142

Number of Not Approvables in the month

Fiscal Year - 2010

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TimeTargetNumber
Oct 2009N/A151
Nov 2009N/A99
Dec 2009N/A128
Jan 2010N/A134
Feb 2010N/A102
Mar 2010N/A160
Apr 2010N/A118
May 2010N/A101
Jun 2010N/A144
Jul 2010N/A131
Aug 2010N/A108
Sep 2010N/A137

FY 2010 Total: 1,514

Number of Pending Applications (cumulative as of end of month)

Dictionary: The pending review queue is affected by the number of new applications submitted, the number of amended applications needing additional review cycles, and the number of applications that cannot be approved due to patents, exclusivities, complex issues or the need to address matters raised in citizen petitions. Overall review capacity affects the capability to address the queue.

Fiscal Year - 2010

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TimeTargetNumber
Oct 2009N/A1,747
Nov 2009N/A1,786
Dec 2009N/A1,912
Jan 2010N/A1,940
Feb 2010N/A1,983
Mar 2010N/A2,068
Apr 2010N/A2,102
May 2010N/A2,101
Jun 2010N/A2,136
Jul 2010N/A2,158
Aug 2010N/A2,198
Sep 2010N/A2,225

FY 2010 Total: 2,236

Number of Pending Applications not blocked by patents (cumulative as of end of month)

Fiscal Year - 2010
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TimeTargetNumber
Oct 2009N/A716
Nov 2009N/A735
Dec 2009N/A768
Jan 2010N/A786
Feb 2010N/A806
Mar 2010N/A827
Apr 2010N/A844
May 2010N/A863
Jun 2010N/A850
Jul 2010N/A859
Aug 2010N/A878
Sep 2010N/A872

FY 2010 Total: 871

Total number of applications received in the month

Fiscal Year - 2010

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TimeTargetNumber
Oct 2009N/A58
Nov 2009N/A57
Dec 2009N/A129
Jan 2010N/A50
Feb 2010N/A57
Mar 2010N/A75
Apr 2010N/A59
May 2010N/A70
Jun 2010N/A78
Jul 2010N/A64
Aug 2010N/A44
Sep 2010N/A73

FY 2010 Total: 813

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.