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U.S. Department of Health and Human Services

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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 June 30, 2014.

Fiscal Year - 2014

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TimeTargetPercent
Oct 201390100
Nov 201390100
Dec 201390100
Jan 201490100
Feb 201490100
Mar 201490100
Apr 201490100
May 201490100
Jun 201490100
Jul 201490TBD
Aug 201490TBD
Sep 201490TBD

FY 2014 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 - 2014
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TimeTargetNumber
Oct 2013N/A13
Nov 2013N/A10
Dec 2013N/A14
Jan 2014N/A13
Feb 2014N/A20
Mar 2014N/A13
Apr 2014N/A10
May 2014N/A24
Jun 2014N/A12
Jul 2014N/ATBD
Aug 2014N/ATBD
Sep 2014N/ATBD

FY 2014 YTD: 129

Number of manufacturing supplemental ANADAs and reactivations of such supplemental applications completed within the month

Fiscal Year - 2014
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TimeTargetNumber
Oct 2013N/A13
Nov 2013N/A10
Dec 2013N/A14
Jan 2014N/A13
Feb 2014N/A20
Mar 2014N/A13
Apr 2014N/A10
May 2014N/A24
Jun 2014N/A12
Jul 2014N/ATBD
Aug 2014N/ATBD
Sep 2014N/ATBD

FY 2014 YTD: 129

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.