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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 - 2013

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

FY 2013 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 - 2013
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TimeTargetNumber
Oct 2012N/A26
Nov 2012N/A13
Dec 2012N/A17
Jan 2013N/A26
Feb 2013N/A16
Mar 2013N/A24
Apr 2013N/A23
May 2013N/A28
Jun 2013N/A29
Jul 2013N/A20
Aug 2013N/A24
Sep 2013N/A13

FY 2013 Total: 259

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

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

TimeTargetNumber
Oct 2012N/A26
Nov 2012N/A13
Dec 2012N/A17
Jan 2013N/A26
Feb 2013N/A16
Mar 2013N/A24
Apr 2013N/A23
May 2013N/A28
Jun 2013N/A29
Jul 2013N/A20
Aug 2013N/A24
Sep 2013N/A13

FY 2013 Total: 259

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.