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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.

• FY 2010
• FY 2011
• FY 2012
• All

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.

Number of Not Approvables in the month

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.

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

Fiscal Year - 2012

Time	Target	Number
Oct 2011	N/A	638
Nov 2011	N/A	629
Dec 2011	N/A	596
Jan 2012	N/A	TBD
Feb 2012	N/A	TBD
Mar 2012	N/A	TBD
Apr 2012	N/A	TBD
May 2012	N/A	TBD
Jun 2012	N/A	TBD
Jul 2012	N/A	TBD
Aug 2012	N/A	TBD
Sep 2012	N/A	TBD

FY 2012 YTD: 596

Total number of applications received in the month

Number of applications approve or tentatively approved for which there is no generic alternative