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U.S. Department of Health and Human Services

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Percentage of manufacturing supplemental NADAs and reactivations of such supplemental applications reviewed within the month that were acted on within 120 days after the submission date

Dictionary: Manufacturing supplemental NADAs are applications in which the sponsor is proposing to make a change in the 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.

Information is current as of June 30, 2014.

Fiscal Year - 2011

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TimeTargetPercent
Oct 201090100
Nov 201090100
Dec 201090100
Jan 201190100
Feb 201190100
Mar 201190100
Apr 201190100
May 201190100
Jun 201190100
Jul 201190100
Aug 201190100
Sep 201190100

FY 2011 Overall: 100

Number of manufacturing supplemental new animal drug applications and reactivations of such supplemental applications reviewed within the month that were acted on within 120 days after the submission date

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/A25
Nov 2010N/A65
Dec 2010N/A36
Jan 2011N/A41
Feb 2011N/A48
Mar 2011N/A44
Apr 2011N/A23
May 2011N/A32
Jun 2011N/A34
Jul 2011N/A32
Aug 2011N/A34
Sep 2011N/A16

FY 2011 Total: 430

Number of manufacturing supplemental new animal drug applications and reactivations of such supplemental applications reviewed and acted on within the month

Fiscal Year - 2011
Skip graphic and jump to text data.

TimeTargetNumber
Oct 2010N/A25
Nov 2010N/A65
Dec 2010N/A36
Jan 2011N/A41
Feb 2011N/A48
Mar 2011N/A44
Apr 2011N/A23
May 2011N/A32
Jun 2011N/A34
Jul 2011N/A32
Aug 2011N/A34
Sep 2011N/A16

FY 2011 Total: 430

Glossary

NADAs

new animal drug applications

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.