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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 - 2012

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TimeTargetPercent
Oct 201190100
Nov 201190100
Dec 201190100
Jan 201290100
Feb 201290100
Mar 201290100
Apr 201290100
May 201290100
Jun 201290100
Jul 201290100
Aug 201290100
Sep 201290100

FY 2012 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 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 - 2012
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TimeTargetNumber
Oct 2011N/A11
Nov 2011N/A15
Dec 2011N/A36
Jan 2012N/A15
Feb 2012N/A11
Mar 2012N/A7
Apr 2012N/A6
May 2012N/A15
Jun 2012N/A15
Jul 2012N/A11
Aug 2012N/A8
Sep 2012N/A8

FY 2012 Total: 158

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

Fiscal Year - 2012
Skip graphic and jump to text data.

TimeTargetNumber
Oct 2011N/A11
Nov 2011N/A15
Dec 2011N/A36
Jan 2012N/A15
Feb 2012N/A11
Mar 2012N/A7
Apr 2012N/A6
May 2012N/A15
Jun 2012N/A15
Jul 2012N/A11
Aug 2012N/A8
Sep 2012N/A8

FY 2012 Total: 158

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.