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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 December 31, 2013.

Fiscal Year - 2012

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TimeTargetPercent
Oct 201190100
Nov 201190100
Dec 201190100
Jan 201290100
Feb 201290100
Mar 201290-
Apr 201290-
May 201290100
Jun 20129050
Jul 201290100
Aug 201290100
Sep 201290100

FY 2012 Overall: 93

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 - 2012
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TimeTargetNumber
Oct 2011N/A2
Nov 2011N/A1
Dec 2011N/A1
Jan 2012N/A2
Feb 2012N/A1
Mar 2012N/A0
Apr 2012N/A0
May 2012N/A3
Jun 2012N/A1
Jul 2012N/A1
Aug 2012N/A1
Sep 2012N/A1

FY 2012 Total: 14

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

Fiscal Year - 2012
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TimeTargetNumber
Oct 2011N/A2
Nov 2011N/A1
Dec 2011N/A1
Jan 2012N/A2
Feb 2012N/A1
Mar 2012N/A0
Apr 2012N/A0
May 2012N/A3
Jun 2012N/A2
Jul 2012N/A1
Aug 2012N/A1
Sep 2012N/A1

FY 2012 Total: 15

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.