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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 - 2011

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TimeTargetPercent
Oct 201090100
Nov 201090100
Dec 201090100
Jan 201190100
Feb 201190100
Mar 201190100
Apr 201190100
May 201190100
Jun 201190100
Jul 201190100
Aug 201190100
Sep 201190100

FY 2011 Overall: 100

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 - 2011
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TimeTargetNumber
Oct 2010N/A6
Nov 2010N/A8
Dec 2010N/A9
Jan 2011N/A18
Feb 2011N/A17
Mar 2011N/A17
Apr 2011N/A20
May 2011N/A20
Jun 2011N/A18
Jul 2011N/A18
Aug 2011N/A19
Sep 2011N/A30

FY 2011 Total: 200

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

Fiscal Year - 2011
Skip graphic and jump to text data.

TimeTargetNumber
Oct 2010N/A6
Nov 2010N/A8
Dec 2010N/A9
Jan 2011N/A18
Feb 2011N/A17
Mar 2011N/A17
Apr 2011N/A20
May 2011N/A20
Jun 2011N/A18
Jul 2011N/A18
Aug 2011N/A19
Sep 2011N/A30

FY 2011 Total: 200

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.