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Number of marketing applications received in the month
Measure was implemented starting January 2010
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 - 2010
Measure was implemented starting January 2010
| Time | Target | Number |
|---|---|---|
| Jan 2010 | N/A | 5 |
| Feb 2010 | N/A | 3 |
| Mar 2010 | N/A | 16 |
| Apr 2010 | N/A | 9 |
| May 2010 | N/A | 7 |
| Jun 2010 | N/A | 7 |
| Jul 2010 | N/A | 10 |
| Aug 2010 | N/A | 5 |
| Sep 2010 | N/A | 7 |
Total number of actions taken on marketing applications during the month
Measure was implemented starting January 2010
Fiscal Year - 2010
Measure was implemented starting January 2010
| Time | Target | Number |
|---|---|---|
| Jan 2010 | N/A | 6 |
| Feb 2010 | N/A | 12 |
| Mar 2010 | N/A | 11 |
| Apr 2010 | N/A | 7 |
| May 2010 | N/A | 9 |
| Jun 2010 | N/A | 10 |
| Jul 2010 | N/A | 10 |
| Aug 2010 | N/A | 12 |
| Sep 2010 | N/A | 8 |
Number of actions taken on marketing applications in the month that were within goal dates
Measure was implemented starting January 2010
Fiscal Year - 2010
Measure was implemented starting January 2010
| Time | Target | Number |
|---|---|---|
| Jan 2010 | N/A | 5 |
| Feb 2010 | N/A | 12 |
| Mar 2010 | N/A | 10 |
| Apr 2010 | N/A | 6 |
| May 2010 | N/A | 9 |
| Jun 2010 | N/A | 10 |
| Jul 2010 | N/A | 10 |
| Aug 2010 | N/A | 10 |
| Sep 2010 | N/A | 8 |
Number of actions taken on marketing applications in the month that were past goal dates
Measure was implemented starting January 2010
Fiscal Year - 2010
Measure was implemented starting January 2010
| Time | Target | Number |
|---|---|---|
| Jan 2010 | N/A | 1 |
| Feb 2010 | N/A | 0 |
| Mar 2010 | N/A | 1 |
| Apr 2010 | N/A | 1 |
| May 2010 | N/A | 0 |
| Jun 2010 | N/A | 0 |
| Jul 2010 | N/A | 0 |
| Aug 2010 | N/A | 2 |
| Sep 2010 | N/A | 0 |
For those actions taken past goal deadlines, median number of days past the goal date
Measure was implemented starting January 2010
Fiscal Year - 2010
Measure was implemented starting January 2010
| Time | Target | Number |
|---|---|---|
| Jan 2010 | N/A | 308 |
| Feb 2010 | N/A | N/A |
| Mar 2010 | N/A | 55 |
| Apr 2010 | N/A | 31 |
| May 2010 | N/A | N/A |
| Jun 2010 | N/A | N/A |
| Jul 2010 | N/A | N/A |
| Aug 2010 | N/A | 609 |
| Sep 2010 | N/A | N/A |
Number of overdue applications at the end of the month
Measure was implemented starting January 2010
Fiscal Year - 2010
Measure was implemented starting January 2010
| Time | Target | Number |
|---|---|---|
| Jan 2010 | N/A | 3 |
| Feb 2010 | N/A | 3 |
| Mar 2010 | N/A | 5 |
| Apr 2010 | N/A | 4 |
| May 2010 | N/A | 5 |
| Jun 2010 | N/A | 5 |
| Jul 2010 | N/A | 5 |
| Aug 2010 | N/A | 3 |
| Sep 2010 | N/A | 4 |
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.







