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U.S. Department of Health and Human Services

About FDA

Number of marketing applications received in the month

Measure was implemented starting January 2010

Dictionary: Marketing Applications (New Drug Applications (NDA) and Biologics License Applications (BLA) are applications to request permission to market a product in the U.S. for a specific use; these applications have legislatively mandated timelines for review.


These measures have been retired as CDER has created new measures for FY13 which align to their four functional areas of 1) Regulatory Review and Drug Safety, 2) Drug Quality and Compliance, 3) Transparency and Public Outreach, and 4) Regulatory Science Research.

Fiscal Year - 2010

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Measure was implemented starting January 2010

TimeTargetNumber
Jan 2010N/A5
Feb 2010N/A3
Mar 2010N/A16
Apr 2010N/A9
May 2010N/A7
Jun 2010N/A7
Jul 2010N/A10
Aug 2010N/A5
Sep 2010N/A7

Total number of actions taken on marketing applications during the month

Measure was implemented starting January 2010

Fiscal Year - 2010

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Measure was implemented starting January 2010

TimeTargetNumber
Jan 2010N/A6
Feb 2010N/A12
Mar 2010N/A11
Apr 2010N/A7
May 2010N/A9
Jun 2010N/A10
Jul 2010N/A10
Aug 2010N/A12
Sep 2010N/A8

Number of actions taken on marketing applications in the month that were within goal dates

Measure was implemented starting January 2010

Fiscal Year - 2010
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Measure was implemented starting January 2010

TimeTargetNumber
Jan 2010N/A5
Feb 2010N/A12
Mar 2010N/A10
Apr 2010N/A6
May 2010N/A9
Jun 2010N/A10
Jul 2010N/A10
Aug 2010N/A10
Sep 2010N/A8

Number of actions taken on marketing applications in the month that were past goal dates

Measure was implemented starting January 2010

Fiscal Year - 2010
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Measure was implemented starting January 2010

TimeTargetNumber
Jan 2010N/A1
Feb 2010N/A0
Mar 2010N/A1
Apr 2010N/A1
May 2010N/A0
Jun 2010N/A0
Jul 2010N/A0
Aug 2010N/A2
Sep 2010N/A0

For those actions taken past goal deadlines, median number of days past the goal date

Measure was implemented starting January 2010

Fiscal Year - 2010

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Measure was implemented starting January 2010

TimeTargetNumber
Jan 2010N/A308
Feb 2010N/AN/A
Mar 2010N/A55
Apr 2010N/A31
May 2010N/AN/A
Jun 2010N/AN/A
Jul 2010N/AN/A
Aug 2010N/A609
Sep 2010N/AN/A

Number of overdue applications at the end of the month

Measure was implemented starting January 2010

Fiscal Year - 2010

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Measure was implemented starting January 2010

TimeTargetNumber
Jan 2010N/A3
Feb 2010N/A3
Mar 2010N/A5
Apr 2010N/A4
May 2010N/A5
Jun 2010N/A5
Jul 2010N/A5
Aug 2010N/A3
Sep 2010N/A4

Glossary

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.