• Decrease
  • Normal
  • Increase
U.S. Department of Health and Human Services

About FDA

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 - 2013

Skip graphic and jump to text data

TimeTargetPercent
Oct 201290100
Nov 201290100
Dec 201290100
Jan 201390100
Feb 201390100
Mar 201390100
Apr 201390100
May 201390100
Jun 201390100
Jul 201390100
Aug 201390100
Sep 201390TBD

FY 2013 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 - 2013
Skip graphic and jump to text data.

TimeTargetNumber
Oct 2012N/A6
Nov 2012N/A11
Dec 2012N/A6
Jan 2013N/A13
Feb 2013N/A5
Mar 2013N/A8
Apr 2013N/A19
May 2013N/A12
Jun 2013N/A7
Jul 2013N/A9
Aug 2013N/A10
Sep 2013N/A12

FY 2013 Total: 118

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

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

TimeTargetNumber
Oct 2012N/A6
Nov 2012N/A11
Dec 2012N/A6
Jan 2013N/A13
Feb 2013N/A5
Mar 2013N/A8
Apr 2013N/A19
May 2013N/A12
Jun 2013N/A7
Jul 2013N/A9
Aug 2013N/A10
Sep 2013N/A12

FY 2013 Total: 118

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.