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U.S. Department of Health and Human Services

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Percentage of INAD submissions consisting of protocols without substantial data reviewed and acted on within the month where the sponsor was notified of the Agency's decision on or before day 50

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 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.

ONADE intends to notify the sponsor within 50 days of receipt of a protocol whether the protocol is acceptable, unacceptable, or requires an end-review amendment. This measure assesses ONADE's timely review and decision making on one aspect of a new animal drug application. Acceptable protocols are critical for the generation of quality data used in the determination of the safety and effectiveness of a new animal drug. (1)

Information is current as of March 31, 2014.

Fiscal Year - 2013

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TimeTargetPercent
Oct 20129088
Nov 201290100
Dec 201290100
Jan 201390100
Feb 201390100
Mar 201390100
Apr 201390100
May 201390100
Jun 201390100
Jul 201390100
Aug 201390100
Sep 201390100

FY 2013 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 submissions consisting of protocols without substantial data reviewed and acted on within the month where the sponsor was notified of the agency's decision on or before day 50

Fiscal Year - 2013
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TimeTargetNumber
Oct 2012N/A7
Nov 2012N/A5
Dec 2012N/A7
Jan 2013N/A10
Feb 2013N/A9
Mar 2013N/A8
Apr 2013N/A11
May 2013N/A7
Jun 2013N/A10
Jul 2013N/A10
Aug 2013N/A11
Sep 2013N/A16

FY 2013 Total: 111

Number of INAD protocols without substantial data reviewed and acted on within the month

Fiscal Year - 2013
Skip graphic and jump to text data.

TimeTargetNumber
Oct 2012N/A8
Nov 2012N/A5
Dec 2012N/A7
Jan 2013N/A10
Feb 2013N/A9
Mar 2013N/A8
Apr 2013N/A11
May 2013N/A7
Jun 2013N/A10
Jul 2013N/A10
Aug 2013N/A11
Sep 2013N/A16

FY 2013 Total: 112

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.