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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 March 31, 2014.

Fiscal Year - 2010

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TimeTargetPercent
Oct 2009N/AN/A
Nov 2009N/AN/A
Dec 2009N/AN/A
Jan 2010N/AN/A
Feb 2010N/AN/A
Mar 2010N/AN/A
Apr 2010N/AN/A
May 2010N/AN/A
Jun 2010N/AN/A
Jul 201090-
Aug 201090-
Sep 201090100

FY 2010 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 - 2010
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TimeTargetNumber
Oct 2009N/AN/A
Nov 2009N/AN/A
Dec 2009N/AN/A
Jan 2010N/AN/A
Feb 2010N/AN/A
Mar 2010N/AN/A
Apr 2010N/AN/A
May 2010N/AN/A
Jun 2010N/AN/A
Jul 2010N/A0
Aug 2010N/A0
Sep 2010N/A7

FY 2010 Total: 7

Number of JINAD submissions consisting of protocols without substantial data completed within the month

Fiscal Year - 2010
Skip graphic and jump to text data.

TimeTargetNumber
Oct 2009N/AN/A
Nov 2009N/AN/A
Dec 2009N/AN/A
Jan 2010N/AN/A
Feb 2010N/AN/A
Mar 2010N/AN/A
Apr 2010N/AN/A
May 2010N/AN/A
Jun 2010N/AN/A
Jul 2010N/A0
Aug 2010N/A0
Sep 2010N/A7

FY 2010 Total: 7

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.