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U.S. Department of Health and Human Services

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Percentage of JINAD submissions consisting of protocols without substantial data completed on time

Dictionary: Sponsors may submit data intended to support an application for generic new animal drug approval during the investigation of the generic new animal drug to a JINAD file. A protocol is a plan for conducting a study that fully describes the objective(s), design, methodology, study endpoints, statistical considerations, and organization of a study. The protocol may include plans for presenting study results in the final study report or submitting study results to FDA in electronic format. Acceptable protocols are critical for the generation of quality data used in the determination of the safety and effectiveness of a generic new animal drug.

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

Information is current as of June 30, 2014.

Fiscal Year - 2013

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

FY 2013 overall: 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 submissions consisting of protocols without substantial data 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/A1
Apr 2013N/A1
May 2013N/A1
Jun 2013N/A1
Jul 2013N/A1
Aug 2013N/A7
Sep 2013N/A5

FY 2013 Total: 17

Number of JINAD submissions consisting of protocols without substantial data 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/A1
Apr 2013N/A1
May 2013N/A1
Jun 2013N/A1
Jul 2013N/A1
Aug 2013N/A7
Sep 2013N/A5

FY 2013 Total: 17

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.