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U.S. Department of Health and Human Services

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Percentage of manufacturing supplemental ANADAs and reactivations of such supplemental applications completed on time

Dictionary: Manufacturing supplemental ANADAs are applications in which the sponsor proposes to make a change in the abbreviated new animal drug manufacturing process. Approval of any changes in the manufacturing of a new animal drug is critical to continued assurance of the quality, safety, and effectiveness of the new animal drug. This measure assesses ONADE's timely review and decision making on one aspect of a new animal drug application.

Note: October 1, 2008 is the effective date of the AGDUFA.

Information is current as of June 30, 2014.

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

  • This metric is also an Animal Generic 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 manufacturing supplemental ANADAs and reactivations of such supplemental applications completed on time

Fiscal Year - 2012
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TimeTargetNumber
Oct 2011N/A11
Nov 2011N/A10
Dec 2011N/A14
Jan 2012N/A14
Feb 2012N/A24
Mar 2012N/A14
Apr 2012N/A6
May 2012N/A14
Jun 2012N/A11
Jul 2012N/A14
Aug 2012N/A23
Sep 2012N/A21

FY 2012 Total: 176

Number of manufacturing supplemental ANADAs and reactivations of such supplemental applications completed within the month

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

TimeTargetNumber
Oct 2011N/A11
Nov 2011N/A10
Dec 2011N/A14
Jan 2012N/A14
Feb 2012N/A24
Mar 2012N/A14
Apr 2012N/A6
May 2012N/A14
Jun 2012N/A11
Jul 2012N/A14
Aug 2012N/A23
Sep 2012N/A21

FY 2012 Total: 176

Glossary

ANADAs

Abbreviated New Animal Drug Applications

AGDUFA

Animal Generic Drug User Fee Act

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.