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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 December 31, 2013.

Fiscal Year - 2010

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TimeTargetPercent
Oct 200990100
Nov 200990100
Dec 200990100
Jan 201090100
Feb 201090100
Mar 201090100
Apr 201090100
May 201090100
Jun 201090100
Jul 201090100
Aug 201090100
Sep 201090100

FY 2010 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 - 2010
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TimeTargetNumber
Oct 2009N/A26
Nov 2009N/A23
Dec 2009N/A42
Jan 2010N/A21
Feb 2010N/A25
Mar 2010N/A32
Apr 2010N/A21
May 2010N/A29
Jun 2010N/A45
Jul 2010N/A27
Aug 2010N/A37
Sep 2010N/A26

FY 2010 Total: 354

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

Fiscal Year - 2010
Skip graphic and jump to text data.

TimeTargetNumber
Oct 2009N/A26
Nov 2009N/A23
Dec 2009N/A42
Jan 2010N/A21
Feb 2010N/A25
Mar 2010N/A32
Apr 2010N/A21
May 2010N/A29
Jun 2010N/A45
Jul 2010N/A27
Aug 2010N/A37
Sep 2010N/A26

FY 2010 Total: 354

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.