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Percentage of JINAD study submissions completed on time
Dictionary: Sponsors may submit data intended to support an application for a generic new animal drug approval during the investigation of the generic new animal drug to a JINAD file. A study submission is a submission containing both the data and conclusions of a study to be considered in support of the approval of a generic new animal drug.
Note: October 1, 2008 is the effective date of the AGDUFA.
Information is current as of February 28, 2013.
Fiscal Year - 2011
| Time | Target | Percent |
|---|---|---|
| Oct 2010 | 90 | 100 |
| Nov 2010 | 90 | - |
| Dec 2010 | 90 | 100 |
| Jan 2011 | 90 | - |
| Feb 2011 | 90 | 100 |
| Mar 2011 | 90 | - |
| Apr 2011 | 90 | - |
| May 2011 | 90 | 100 |
| Jun 2011 | 90 | 100 |
| Jul 2011 | 90 | 100 |
| Aug 2011 | 90 | 100 |
| Sep 2011 | 90 | 100 |
FY 2011 Overall: 100
Footnotes
- This metric is also an Animal Generic Drug User Fee Program performance goal. In the yearly performance report to Congress, performance is reported for a defined fiscal year receipt cohort. The methodology for reporting by fiscal year receipt cohort calculates performance statistics for submissions for the fiscal year FDA received them, regardless of when FDA ultimately acted on or approved the submissions. The data reported here is the measurement of the number of applications reviewed in a given month regardless of the cohort year.
Number of JINAD study submissions completed on time
Fiscal Year - 2011
| Time | Target | Number |
|---|---|---|
| Oct 2010 | N/A | 2 |
| Nov 2010 | N/A | 0 |
| Dec 2010 | N/A | 1 |
| Jan 2011 | N/A | 0 |
| Feb 2011 | N/A | 2 |
| Mar 2011 | N/A | 0 |
| Apr 2011 | N/A | 0 |
| May 2011 | N/A | 3 |
| Jun 2011 | N/A | 4 |
| Jul 2011 | N/A | 2 |
| Aug 2011 | N/A | 1 |
| Sep 2011 | N/A | 5 |
FY 2011 Total: 20
Number of JINAD study submissions completed within the month
Fiscal Year - 2011
| Time | Target | Number |
|---|---|---|
| Oct 2010 | N/A | 2 |
| Nov 2010 | N/A | 0 |
| Dec 2010 | N/A | 1 |
| Jan 2011 | N/A | 0 |
| Feb 2011 | N/A | 2 |
| Mar 2011 | N/A | 0 |
| Apr 2011 | N/A | 0 |
| May 2011 | N/A | 3 |
| Jun 2011 | N/A | 4 |
| Jul 2011 | N/A | 2 |
| Aug 2011 | N/A | 1 |
| Sep 2011 | N/A | 5 |
FY 2011 Total: 20
Glossary
JINAD
Generic Investigational New Animal Drug
AGDUFA
Animal Generic Drug User Fee Act
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.
