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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 - 2010
| Time | Target | Percent |
|---|---|---|
| Oct 2009 | 90 | 100 |
| Nov 2009 | 90 | 100 |
| Dec 2009 | 90 | 100 |
| Jan 2010 | 90 | 100 |
| Feb 2010 | 90 | 100 |
| Mar 2010 | 90 | 100 |
| Apr 2010 | 90 | 100 |
| May 2010 | 90 | 100 |
| Jun 2010 | 90 | 100 |
| Jul 2010 | 90 | 100 |
| Aug 2010 | 90 | 100 |
| Sep 2010 | 90 | 100 |
FY 2010 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 - 2010
| Time | Target | Number |
|---|---|---|
| Oct 2009 | N/A | 26 |
| Nov 2009 | N/A | 23 |
| Dec 2009 | N/A | 42 |
| Jan 2010 | N/A | 21 |
| Feb 2010 | N/A | 25 |
| Mar 2010 | N/A | 32 |
| Apr 2010 | N/A | 21 |
| May 2010 | N/A | 29 |
| Jun 2010 | N/A | 45 |
| Jul 2010 | N/A | 27 |
| Aug 2010 | N/A | 37 |
| Sep 2010 | N/A | 26 |
FY 2010 Total: 354
Number of manufacturing supplemental new animal drug applications and reactivations of such supplemental applications reviewed and acted on within the month
Fiscal Year - 2010
| Time | Target | Number |
|---|---|---|
| Oct 2009 | N/A | 26 |
| Nov 2009 | N/A | 23 |
| Dec 2009 | N/A | 42 |
| Jan 2010 | N/A | 21 |
| Feb 2010 | N/A | 25 |
| Mar 2010 | N/A | 32 |
| Apr 2010 | N/A | 21 |
| May 2010 | N/A | 29 |
| Jun 2010 | N/A | 45 |
| Jul 2010 | N/A | 27 |
| Aug 2010 | N/A | 37 |
| Sep 2010 | N/A | 26 |
FY 2010 Total: 354
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.
