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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 December 31, 2013.

Fiscal Year - 2010

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TimeTargetPercent
Oct 200990100
Nov 20099086
Dec 200990100
Jan 201090100
Feb 201090100
Mar 201090100
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 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 - 2010
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TimeTargetNumber
Oct 2009N/A10
Nov 2009N/A6
Dec 2009N/A18
Jan 2010N/A8
Feb 2010N/A9
Mar 2010N/A5
Apr 2010N/A9
May 2010N/A14
Jun 2010N/A12
Jul 2010N/A7
Aug 2010N/A8
Sep 2010N/A8

FY 2010 Total: 114

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

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

TimeTargetNumber
Oct 2009N/A10
Nov 2009N/A7
Dec 2009N/A18
Jan 2010N/A8
Feb 2010N/A9
Mar 2010N/A5
Apr 2010N/A9
May 2010N/A14
Jun 2010N/A12
Jul 2010N/A7
Aug 2010N/A8
Sep 2010N/A8

FY 2010 Total: 115

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.