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Number of marketing applications received in the month
Dictionary: Marketing Applications (New Drug Applications (NDA) and Biologics License Applications (BLA) are applications to request permission to market a product in the U.S. for a specific use; these applications have legislatively mandated timelines for review.
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
| Time | Target | Number |
|---|---|---|
| Oct 2010 | N/A | 5 |
| Nov 2010 | N/A | 12 |
| Dec 2010 | N/A | 14 |
| Jan 2011 | N/A | 10 |
| Feb 2011 | N/A | 12 |
| Mar 2011 | N/A | 8 |
| Apr 2011 | N/A | 11 |
| May 2011 | N/A | 5 |
| Jun 2011 | N/A | 9 |
| Jul 2011 | N/A | 7 |
| Aug 2011 | N/A | 10 |
| Sep 2011 | N/A | 13 |
FY 2011 Total: 116
Total number of actions taken on marketing applications during the month
Fiscal Year - 2011
| Time | Target | Number |
|---|---|---|
| Oct 2010 | N/A | 19 |
| Nov 2010 | N/A | 12 |
| Dec 2010 | N/A | 8 |
| Jan 2011 | N/A | 14 |
| Feb 2011 | N/A | 9 |
| Mar 2011 | N/A | 12 |
| Apr 2011 | N/A | 8 |
| May 2011 | N/A | 9 |
| Jun 2011 | N/A | 7 |
| Jul 2011 | N/A | 3 |
| Aug 2011 | N/A | 13 |
| Sep 2011 | N/A | 7 |
FY 2011 Total: 121
Number of actions taken on marketing applications in the month that were within goal dates
Fiscal Year - 2011
| Time | Target | Number |
|---|---|---|
| Oct 2010 | N/A | 19 |
| Nov 2010 | N/A | 8 |
| Dec 2010 | N/A | 8 |
| Jan 2011 | N/A | 13 |
| Feb 2011 | N/A | 9 |
| Mar 2011 | N/A | 11 |
| Apr 2011 | N/A | 8 |
| May 2011 | N/A | 9 |
| Jun 2011 | N/A | 7 |
| Jul 2011 | N/A | 3 |
| Aug 2011 | N/A | 13 |
| Sep 2011 | N/A | 7 |
FY 2011 Total: 115
Number of actions taken on marketing applications in the month that were past goal dates
Fiscal Year - 2011
| Time | Target | Number |
|---|---|---|
| Oct 2010 | N/A | 0 |
| Nov 2010 | N/A | 4 |
| Dec 2010 | N/A | 0 |
| Jan 2011 | N/A | 1 |
| Feb 2011 | N/A | 0 |
| Mar 2011 | N/A | 1 |
| Apr 2011 | N/A | 0 |
| May 2011 | N/A | 0 |
| Jun 2011 | N/A | 0 |
| Jul 2011 | N/A | 0 |
| Aug 2011 | N/A | 0 |
| Sep 2011 | N/A | 0 |
FY 2011 Total: 6
For those actions taken past goal deadlines, median number of days past the goal date
Fiscal Year - 2011
| Time | Target | Number |
|---|---|---|
| Oct 2010 | N/A | N/A |
| Nov 2010 | N/A | 214 |
| Dec 2010 | N/A | N/A |
| Jan 2011 | N/A | 124 |
| Feb 2011 | N/A | N/A |
| Mar 2011 | N/A | 102 |
| Apr 2011 | N/A | N/A |
| May 2011 | N/A | N/A |
| Jun 2011 | N/A | N/A |
| Jul 2011 | N/A | N/A |
| Aug 2011 | N/A | N/A |
| Sep 2011 | N/A | N/A |
Number of overdue applications at the end of the month
Fiscal Year - 2011
| Time | Target | Number |
|---|---|---|
| Oct 2010 | N/A | 4 |
| Nov 2010 | N/A | 1 |
| Dec 2010 | N/A | 2 |
| Jan 2011 | N/A | 1 |
| Feb 2011 | N/A | 1 |
| Mar 2011 | N/A | 0 |
| Apr 2011 | N/A | 0 |
| May 2011 | N/A | 0 |
| Jun 2011 | N/A | 0 |
| Jul 2011 | N/A | 0 |
| Aug 2011 | N/A | 1 |
| Sep 2011 | N/A | 1 |
FY 2011 Total: 13
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.
