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U.S. Department of Health and Human Services

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Percentage of INAD study submissions reviewed within the month that were acted on within 180 days after the submission date

Dictionary: Sponsors may submit data intended to support an application for new animal drug approval during the investigation of the new animal drug to an INAD 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 new animal drug. This measure assesses ONADE's timely review and decision making on one aspect of a new animal drug application. (1)

Information is current as of March 31, 2014.

Fiscal Year - 2010

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TimeTargetPercent
Oct 200990100
Nov 200990100
Dec 200990100
Jan 201090100
Feb 201090100
Mar 20109097
Apr 201090100
May 201090100
Jun 201090100
Jul 201090100
Aug 201090100
Sep 201090100

FY 2010 Overall: 99

Footnotes

  • (1) This metric is also an Animal 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 INAD study submissions reviewed within the month that were acted upon within 180 days after the submission date

Fiscal Year - 2010
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TimeTargetNumber
Oct 2009N/A24
Nov 2009N/A21
Dec 2009N/A23
Jan 2010N/A23
Feb 2010N/A22
Mar 2010N/A30
Apr 2010N/A14
May 2010N/A29
Jun 2010N/A17
Jul 2010N/A16
Aug 2010N/A39
Sep 2010N/A14

FY 2010 Total: 272

Number of INAD study submissions reviewed and acted on within the month

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

TimeTargetNumber
Oct 2009N/A24
Nov 2009N/A21
Dec 2009N/A23
Jan 2010N/A23
Feb 2010N/A22
Mar 2010N/A31
Apr 2010N/A14
May 2010N/A29
Jun 2010N/A17
Jul 2010N/A16
Aug 2010N/A39
Sep 2010N/A14

FY 2010 Total: 273

Glossary

INAD

Investigational New Animal Drug

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.