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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 - 2012

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TimeTargetPercent
Oct 201190100
Nov 201190100
Dec 201190100
Jan 201290100
Feb 201290100
Mar 201290100
Apr 201290100
May 201290100
Jun 201290100
Jul 201290100
Aug 201290100
Sep 201290100

FY 2012 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 - 2012
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TimeTargetNumber
Oct 2011N/A19
Nov 2011N/A48
Dec 2011N/A26
Jan 2012N/A23
Feb 2012N/A26
Mar 2012N/A17
Apr 2012N/A27
May 2012N/A32
Jun 2012N/A31
Jul 2012N/A25
Aug 2012N/A32
Sep 2012N/A22

FY 2012 Total: 328

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

Fiscal Year - 2012
Skip graphic and jump to text data.

TimeTargetNumber
Oct 2011N/A19
Nov 2011N/A48
Dec 2011N/A26
Jan 2012N/A23
Feb 2012N/A26
Mar 2012N/A17
Apr 2012N/A27
May 2012N/A32
Jun 2012N/A31
Jul 2012N/A25
Aug 2012N/A32
Sep 2012N/A22

FY 2012 Total: 328

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.