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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
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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

Time	Target	Number
Oct 2011	N/A	11
Nov 2011	N/A	10
Dec 2011	N/A	14
Jan 2012	N/A	14
Feb 2012	N/A	24
Mar 2012	N/A	14
Apr 2012	N/A	6
May 2012	N/A	14
Jun 2012	N/A	11
Jul 2012	N/A	14
Aug 2012	N/A	23
Sep 2012	N/A	21

FY 2012 Total: 176

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

Fiscal Year - 2012

Time	Target	Number
Oct 2011	N/A	11
Nov 2011	N/A	10
Dec 2011	N/A	14
Jan 2012	N/A	14
Feb 2012	N/A	24
Mar 2012	N/A	14
Apr 2012	N/A	6
May 2012	N/A	14
Jun 2012	N/A	11
Jul 2012	N/A	14
Aug 2012	N/A	23
Sep 2012	N/A	21

FY 2012 Total: 176