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U.S. Department of Health and Human Services

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Percentage of JINAD study submissions completed on time

Dictionary: Sponsors may submit data intended to support an application for a generic new animal drug approval during the investigation of the generic new animal drug to a JINAD file. A study submission is a submission containing both the data and conclusions of a study to be considered in support of the approval of a generic new animal drug.

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

Information is current as of March 31, 2014.

Fiscal Year - 2014

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TimeTargetPercent
Oct 201390100
Nov 201390100
Dec 201390100
Jan 201490100
Feb 201490-
Mar 201490-
Apr 201490TBD
May 201490TBD
Jun 201490TBD
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 JINAD study submissions completed on time

Fiscal Year - 2014
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TimeTargetNumber
Oct 2013N/A1
Nov 2013N/A3
Dec 2013N/A3
Jan 2014N/A7
Feb 2014N/A0
Mar 2014N/A0
Apr 2014N/ATBD
May 2014N/ATBD
Jun 2014N/ATBD
Jul 2014N/ATBD
Aug 2014N/ATBD
Sep 2014N/ATBD

FY 2014 YTD: 14

Number of JINAD study submissions completed within the month

Fiscal Year - 2014
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TimeTargetNumber
Oct 2013N/A1
Nov 2013N/A3
Dec 2013N/A3
Jan 2014N/A7
Feb 2014N/A0
Mar 2014N/A0
Apr 2014N/ATBD
May 2014N/ATBD
Jun 2014N/ATBD
Jul 2014N/ATBD
Aug 2014N/ATBD
Sep 2014N/ATBD

FY 2014 YTD: 14

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.