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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 February 28, 2013.

• FY 2010
• FY 2011
• FY 2012
• FY 2013
• All

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 - 2011

Time	Target	Number
Oct 2010	N/A	13
Nov 2010	N/A	14
Dec 2010	N/A	14
Jan 2011	N/A	16
Feb 2011	N/A	16
Mar 2011	N/A	12
Apr 2011	N/A	9
May 2011	N/A	16
Jun 2011	N/A	6
Jul 2011	N/A	19
Aug 2011	N/A	18
Sep 2011	N/A	32

FY 2011 Total: 185

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

Fiscal Year - 2011

Time	Target	Number
Oct 2010	N/A	13
Nov 2010	N/A	14
Dec 2010	N/A	14
Jan 2011	N/A	16
Feb 2011	N/A	16
Mar 2011	N/A	12
Apr 2011	N/A	9
May 2011	N/A	16
Jun 2011	N/A	6
Jul 2011	N/A	19
Aug 2011	N/A	18
Sep 2011	N/A	32

FY 2011 Total: 185