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U.S. Department of Health and Human Services

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Percentage of administrative ANADAs (ANADAs submitted after all scientific decisions have been made in the JINAD process) completed on time

Dictionary: A generic new animal drug is a copy of an approved new animal drug for which patents or other periods of exclusivity are near expiration. In order for a generic animal drug to be marketed in the United States, it must be the subject of an approved ANADA. Administrative ANADAs are submitted after all scientific decisions have been made in the JINAD process.

Note: October 1, 2008 is the effective date of the AGDUFA.

Information is current as of December 31, 2013.

Fiscal Year - 2013

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TimeTargetPercent
Oct 201290-
Nov 201290-
Dec 201290-
Jan 201390-
Feb 201390-
Mar 201390-
Apr 201390100
May 201390-
Jun 201390100
Jul 201390-
Aug 201390-
Sep 201390-

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 administrative ANADAs completed on time

Fiscal Year - 2013
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TimeTargetNumber
Oct 2012N/A0
Nov 2012N/A0
Dec 2012N/A0
Jan 2013N/A0
Feb 2013N/A0
Mar 2013N/A0
Apr 2013N/A1
May 2013N/A0
Jun 2013N/A1
Jul 2013N/A0
Aug 2013N/A0
Sep 2013N/A0

FY 2013 YTD: 2

Number of administrative ANADAs completed within the month

Fiscal Year - 2013
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TimeTargetNumber
Oct 2012N/A0
Nov 2012N/A0
Dec 2012N/A0
Jan 2013N/A0
Feb 2013N/A0
Mar 2013N/A0
Apr 2013N/A1
May 2013N/A0
Jun 2013N/A1
Jul 2013N/A0
Aug 2013N/A0
Sep 2013N/A0

FY 2013 YTD: 2

Glossary

JINAD

Generic Investigational New Animal Drug

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.