• Decrease
  • Normal
  • Increase
U.S. Department of Health and Human Services

About FDA

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 - 2011

Skip graphic and jump to text data

TimeTargetNumber
Oct 2010N/A39
Nov 2010N/A28
Dec 2010N/A39
Jan 2011N/A27
Feb 2011N/A35
Mar 2011N/A45
Apr 2011N/A30
May 2011N/A52
Jun 2011N/A56
Jul 2011N/A50
Aug 2011N/A27
Sep 2011N/A30

FY 2011 Total: 458

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 - 2011

Skip graphic and jump to text data

TimeTargetNumber
Oct 2010N/A13
Nov 2010N/A9
Dec 2010N/A12
Jan 2011N/A13
Feb 2011N/A10
Mar 2011N/A12
Apr 2011N/A17
May 2011N/A6
Jun 2011N/A4
Jul 2011N/A9
Aug 2011N/A20
Sep 2011N/A14

FY 2011 Total: 139

Number of Not Approvables in the month

Fiscal Year - 2011

Skip graphic and jump to text data

TimeTargetNumber
Oct 2010N/A139
Nov 2010N/A130
Dec 2010N/A144
Jan 2011N/A157
Feb 2011N/A140
Mar 2011N/A149
Apr 2011N/A133
May 2011N/A102
Jun 2011N/A180
Jul 2011N/A116
Aug 2011N/A167
Sep 2011N/A122

FY 2011 Total: 1,679

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 - 2011

Skip graphic and jump to text data

TimeTargetNumber
Oct 2010N/A2,247
Nov 2010N/A2,280
Dec 2010N/A2,361
Jan 2011N/A2,356
Feb 2011N/A2,390
Mar 2011N/A2,448
Apr 2011N/A2,479
May 2011N/A2,485
Jun 2011N/A2,478
Jul 2011N/A2,485
Aug 2011N/A2,485
Sep 2011N/A2,500

FY 2011 Total: 2,500

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

Fiscal Year - 2011
Skip graphic and jump to text data.

TimeTargetNumber
Oct 2010N/A856
Nov 2010N/A840
Dec 2010N/A820
Jan 2011N/A808
Feb 2011N/A794
Mar 2011N/A776
Apr 2011N/A749
May 2011N/A746
Jun 2011N/A722
Jul 2011N/A695
Aug 2011N/A677
Sep 2011N/A659

FY 2011 Total: 659

Total number of applications received in the month

Fiscal Year - 2011

Skip graphic and jump to text data

TimeTargetNumber
Oct 2010N/A78
Nov 2010N/A85
Dec 2010N/A122
Jan 2011N/A70
Feb 2011N/A55
Mar 2011N/A98
Apr 2011N/A75
May 2011N/A69
Jun 2011N/A69
Jul 2011N/A56
Aug 2011N/A55
Sep 2011N/A61

FY 2011 Total: 893

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

Fiscal Year - 2011

Skip graphic and jump to text data

TimeTargetNumber
Oct 2010N/AN/A
Nov 2010N/AN/A
Dec 2010N/AN/A
Jan 2011N/AN/A
Feb 2011N/AN/A
Mar 2011N/AN/A
Apr 2011N/AN/A
May 2011N/AN/A
Jun 2011N/AN/A
Jul 2011N/AN/A
Aug 2011N/AN/A
Sep 2011N/A11

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.