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Percentage of JINAD submissions consisting of protocols without substantial data completed on time
Dictionary: Sponsors may submit data intended to support an application for generic new animal drug approval during the investigation of the generic new animal drug to a JINAD file. A protocol is a plan for conducting a study that fully describes the objective(s), design, methodology, study endpoints, statistical considerations, and organization of a study. The protocol may include plans for presenting study results in the final study report or submitting study results to FDA in electronic format. Acceptable protocols are critical for the generation of quality data used in the determination of the safety and effectiveness 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 - 2013
| Time | Fiscal Year Target | Percent |
|---|---|---|
| Oct 2012 | 90 | - |
| Nov 2012 | 90 | - |
| Dec 2012 | 90 | - |
| Jan 2013 | 90 | - |
| Feb 2013 | 90 | - |
| Mar 2013 | 90 | TBD |
| Apr 2013 | 90 | TBD |
| May 2013 | 90 | TBD |
| Jun 2013 | 90 | TBD |
| Jul 2013 | 90 | TBD |
| Aug 2013 | 90 | TBD |
| Sep 2013 | 90 | TBD |
FY 2013 YTD: -
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 submissions consisting of protocols without substantial data completed on time
Fiscal Year - 2013
| Time | Fiscal Year Target | Number |
|---|---|---|
| Oct 2012 | N/A | 0 |
| Nov 2012 | N/A | 0 |
| Dec 2012 | N/A | 0 |
| Jan 2013 | N/A | 0 |
| Feb 2013 | N/A | 0 |
| Mar 2013 | N/A | TBD |
| Apr 2013 | N/A | TBD |
| May 2013 | N/A | TBD |
| Jun 2013 | N/A | TBD |
| Jul 2013 | N/A | TBD |
| Aug 2013 | N/A | TBD |
| Sep 2013 | N/A | TBD |
FY 2013 YTD: 0
Number of JINAD submissions consisting of protocols without substantial data completed within the month
Fiscal Year - 2013
| Time | Fiscal Year Target | Number |
|---|---|---|
| Oct 2012 | N/A | 0 |
| Nov 2012 | N/A | 0 |
| Dec 2012 | N/A | 0 |
| Jan 2013 | N/A | 0 |
| Feb 2013 | N/A | 0 |
| Mar 2013 | N/A | TBD |
| Apr 2013 | N/A | TBD |
| May 2013 | N/A | TBD |
| Jun 2013 | N/A | TBD |
| Jul 2013 | N/A | TBD |
| Aug 2013 | N/A | TBD |
| Sep 2013 | N/A | TBD |
FY 2013 YTD: 0
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.
