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Percentage of manufacturing supplemental ANADAs and reactivations of such supplemental applications completed on time
Dictionary: Manufacturing supplemental ANADAs are applications in which the sponsor proposes to make a change in the abbreviated new animal drug manufacturing process. Approval of any changes in the manufacturing of a new animal drug is critical to continued assurance of the quality, safety, and effectiveness of the new animal drug. This measure assesses ONADE's timely review and decision making on one aspect of a new animal drug application.
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 | 100 |
| Nov 2012 | 90 | 100 |
| Dec 2012 | 90 | 100 |
| Jan 2013 | 90 | 100 |
| Feb 2013 | 90 | 100 |
| 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: 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 manufacturing supplemental ANADAs and reactivations of such supplemental applications completed on time
Fiscal Year - 2013
| Time | Fiscal Year Target | Number |
|---|---|---|
| Oct 2012 | N/A | 6 |
| Nov 2012 | N/A | 11 |
| Dec 2012 | N/A | 6 |
| Jan 2013 | N/A | 13 |
| Feb 2013 | N/A | 5 |
| 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: 41
Number of manufacturing supplemental ANADAs and reactivations of such supplemental applications completed within the month
Fiscal Year - 2013
| Time | Fiscal Year Target | Number |
|---|---|---|
| Oct 2012 | N/A | 6 |
| Nov 2012 | N/A | 11 |
| Dec 2012 | N/A | 6 |
| Jan 2013 | N/A | 13 |
| Feb 2013 | N/A | 5 |
| 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: 41
Glossary
ANADAs
Abbreviated New Animal Drug Applications
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.
