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U.S. Department of Health and Human Services

About FDA

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 - 2014

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TimeTargetPercent
Oct 201390100
Nov 201390100
Dec 201390100
Jan 201490TBD
Feb 201490TBD
Mar 201490TBD
Apr 201490TBD
May 201490TBD
Jun 201490TBD
Jul 201490TBD
Aug 201490TBD
Sep 201490TBD

FY 2014 YTD: 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 - 2014
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TimeTargetNumber
Oct 2013N/A24
Nov 2013N/A20
Dec 2013N/A30
Jan 2014N/ATBD
Feb 2014N/ATBD
Mar 2014N/ATBD
Apr 2014N/ATBD
May 2014N/ATBD
Jun 2014N/ATBD
Jul 2014N/ATBD
Aug 2014N/ATBD
Sep 2014N/ATBD

FY 2014 YTD: 74

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

Fiscal Year - 2014
Skip graphic and jump to text data.

TimeTargetNumber
Oct 2013N/A24
Nov 2013N/A20
Dec 2013N/A30
Jan 2014N/ATBD
Feb 2014N/ATBD
Mar 2014N/ATBD
Apr 2014N/ATBD
May 2014N/ATBD
Jun 2014N/ATBD
Jul 2014N/ATBD
Aug 2014N/ATBD
Sep 2014N/ATBD

FY 2014 YTD: 74

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.