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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 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%
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 - 2013
| Time | Fiscal Year Target | Number |
|---|---|---|
| Oct 2012 | N/A | 26 |
| Nov 2012 | N/A | 13 |
| Dec 2012 | N/A | 17 |
| Jan 2013 | N/A | 26 |
| Feb 2013 | N/A | 16 |
| 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: 98
Number of manufacturing supplemental new animal drug applications and reactivations of such supplemental applications reviewed and acted on within the month
Fiscal Year - 2013
| Time | Fiscal Year Target | Number |
|---|---|---|
| Oct 2012 | N/A | 26 |
| Nov 2012 | N/A | 13 |
| Dec 2012 | N/A | 17 |
| Jan 2013 | N/A | 26 |
| Feb 2013 | N/A | 16 |
| 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: 98
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.
