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Percentage of manufacturing supplemental NADAs and reactivations of such supplemental applications reviewed within the month that were acted on within 120 days after the submission date
Dictionary: Manufacturing supplemental NADAs are applications in which the sponsor is proposing to make a change in the 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.
Information is current as of November 30, 2012.
Fiscal Year - 2012
| Time | Target | Percent |
|---|---|---|
| Oct 2011 | 90 | 100 |
| Nov 2011 | 90 | 100 |
| Dec 2011 | 90 | 100 |
| Jan 2012 | 90 | 100 |
| Feb 2012 | 90 | 100 |
| Mar 2012 | 90 | 100 |
| Apr 2012 | 90 | 100 |
| May 2012 | 90 | 100 |
| Jun 2012 | 90 | 100 |
| Jul 2012 | 90 | 100 |
| Aug 2012 | 90 | 100 |
| Sep 2012 | 90 | 100 |
FY 2012 Overall: 100
Number of manufacturing supplemental new animal drug applications and reactivations of such supplemental applications reviewed within the month that were acted on within 120 days after the submission date
Fiscal Year - 2012
| Time | Target | Number |
|---|---|---|
| Oct 2011 | N/A | 19 |
| Nov 2011 | N/A | 48 |
| Dec 2011 | N/A | 26 |
| Jan 2012 | N/A | 23 |
| Feb 2012 | N/A | 26 |
| Mar 2012 | N/A | 17 |
| Apr 2012 | N/A | 27 |
| May 2012 | N/A | 32 |
| Jun 2012 | N/A | 31 |
| Jul 2012 | N/A | 25 |
| Aug 2012 | N/A | 32 |
| Sep 2012 | N/A | 22 |
FY 2012 Total: 328
Number of manufacturing supplemental new animal drug applications and reactivations of such supplemental applications reviewed and acted on within the month
Fiscal Year - 2012
| Time | Target | Number |
|---|---|---|
| Oct 2011 | N/A | 19 |
| Nov 2011 | N/A | 48 |
| Dec 2011 | N/A | 26 |
| Jan 2012 | N/A | 23 |
| Feb 2012 | N/A | 26 |
| Mar 2012 | N/A | 17 |
| Apr 2012 | N/A | 27 |
| May 2012 | N/A | 32 |
| Jun 2012 | N/A | 31 |
| Jul 2012 | N/A | 25 |
| Aug 2012 | N/A | 32 |
| Sep 2012 | N/A | 22 |
FY 2012 Total: 328
Glossary
NADAs
new animal drug applications
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.
