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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
| Time | Target | Number |
|---|---|---|
| Oct 2009 | N/A | 25 |
| Nov 2009 | N/A | 43 |
| Dec 2009 | N/A | 31 |
| Jan 2010 | N/A | 18 |
| Feb 2010 | N/A | 26 |
| Mar 2010 | N/A | 28 |
| Apr 2010 | N/A | 46 |
| May 2010 | N/A | 44 |
| Jun 2010 | N/A | 64 |
| Jul 2010 | N/A | 42 |
| Aug 2010 | N/A | 30 |
| Sep 2010 | N/A | 29 |
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
| Time | Target | Number |
|---|---|---|
| Oct 2009 | N/A | 8 |
| Nov 2009 | N/A | 9 |
| Dec 2009 | N/A | 15 |
| Jan 2010 | N/A | 19 |
| Feb 2010 | N/A | 4 |
| Mar 2010 | N/A | 9 |
| Apr 2010 | N/A | 17 |
| May 2010 | N/A | 19 |
| Jun 2010 | N/A | 12 |
| Jul 2010 | N/A | 8 |
| Aug 2010 | N/A | 11 |
| Sep 2010 | N/A | 11 |
FY 2010 Total: 142
Number of Not Approvables in the month
Fiscal Year - 2010
| Time | Target | Number |
|---|---|---|
| Oct 2009 | N/A | 151 |
| Nov 2009 | N/A | 99 |
| Dec 2009 | N/A | 128 |
| Jan 2010 | N/A | 134 |
| Feb 2010 | N/A | 102 |
| Mar 2010 | N/A | 160 |
| Apr 2010 | N/A | 118 |
| May 2010 | N/A | 101 |
| Jun 2010 | N/A | 144 |
| Jul 2010 | N/A | 131 |
| Aug 2010 | N/A | 108 |
| Sep 2010 | N/A | 137 |
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
| Time | Target | Number |
|---|---|---|
| Oct 2009 | N/A | 1,747 |
| Nov 2009 | N/A | 1,786 |
| Dec 2009 | N/A | 1,912 |
| Jan 2010 | N/A | 1,940 |
| Feb 2010 | N/A | 1,983 |
| Mar 2010 | N/A | 2,068 |
| Apr 2010 | N/A | 2,102 |
| May 2010 | N/A | 2,101 |
| Jun 2010 | N/A | 2,136 |
| Jul 2010 | N/A | 2,158 |
| Aug 2010 | N/A | 2,198 |
| Sep 2010 | N/A | 2,225 |
FY 2010 Total: 2,236
Number of Pending Applications not blocked by patents (cumulative as of end of month)
Fiscal Year - 2010
| Time | Target | Number |
|---|---|---|
| Oct 2009 | N/A | 716 |
| Nov 2009 | N/A | 735 |
| Dec 2009 | N/A | 768 |
| Jan 2010 | N/A | 786 |
| Feb 2010 | N/A | 806 |
| Mar 2010 | N/A | 827 |
| Apr 2010 | N/A | 844 |
| May 2010 | N/A | 863 |
| Jun 2010 | N/A | 850 |
| Jul 2010 | N/A | 859 |
| Aug 2010 | N/A | 878 |
| Sep 2010 | N/A | 872 |
FY 2010 Total: 871
Total number of applications received in the month
Fiscal Year - 2010
| Time | Target | Number |
|---|---|---|
| Oct 2009 | N/A | 58 |
| Nov 2009 | N/A | 57 |
| Dec 2009 | N/A | 129 |
| Jan 2010 | N/A | 50 |
| Feb 2010 | N/A | 57 |
| Mar 2010 | N/A | 75 |
| Apr 2010 | N/A | 59 |
| May 2010 | N/A | 70 |
| Jun 2010 | N/A | 78 |
| Jul 2010 | N/A | 64 |
| Aug 2010 | N/A | 44 |
| Sep 2010 | N/A | 73 |
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.
