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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 June 30, 2014.

Fiscal Year - 2014

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TimeTargetPercent
Oct 20139097
Nov 20139085
Dec 20139097
Jan 201490100
Feb 201490100
Mar 201490100
Apr 201490100
May 201490100
Jun 201490100
Jul 201490TBD
Aug 201490TBD
Sep 201490TBD

FY 2014 YTD: 97%

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 - 2014
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TimeTargetNumber
Oct 2013N/A30
Nov 2013N/A17
Dec 2013N/A32
Jan 2014N/A15
Feb 2014N/A14
Mar 2014N/A23
Apr 2014N/A18
May 2014N/A17
Jun 2014N/A26
Jul 2014N/ATBD
Aug 2014N/ATBD
Sep 2014N/ATBD

FY 2014 YTD: 192

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

Fiscal Year - 2014
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TimeTargetNumber
Oct 2013N/A31
Nov 2013N/A20
Dec 2013N/A33
Jan 2014N/A15
Feb 2014N/A14
Mar 2014N/A23
Apr 2014N/A18
May 2014N/A17
Jun 2014N/A26
Jul 2014N/ATBD
Aug 2014N/ATBD
Sep 2014N/ATBD

FY 2014 YTD: 197

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.