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U.S. Department of Health and Human Services

About FDA

Number of marketing applications received in the month

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 - 2012

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TimeTargetNumber
Oct 2011N/A6
Nov 2011N/A9
Dec 2011N/A24
Jan 2012N/ATBD
Feb 2012N/ATBD
Mar 2012N/ATBD
Apr 2012N/ATBD
May 2012N/ATBD
Jun 2012N/ATBD
Jul 2012N/ATBD
Aug 2012N/ATBD
Sep 2012N/ATBD

FY 2012 YTD: 39

Total number of actions taken on marketing applications during the month

Fiscal Year - 2012

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TimeTargetNumber
Oct 2011N/A6
Nov 2011N/A13
Dec 2011N/A9
Jan 2012N/ATBD
Feb 2012N/ATBD
Mar 2012N/ATBD
Apr 2012N/ATBD
May 2012N/ATBD
Jun 2012N/ATBD
Jul 2012N/ATBD
Aug 2012N/ATBD
Sep 2012N/ATBD

FY 2012 YTD: 28

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

Fiscal Year - 2012
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TimeTargetNumber
Oct 2011N/A6
Nov 2011N/A11
Dec 2011N/A9
Jan 2012N/ATBD
Feb 2012N/ATBD
Mar 2012N/ATBD
Apr 2012N/ATBD
May 2012N/ATBD
Jun 2012N/ATBD
Jul 2012N/ATBD
Aug 2012N/ATBD
Sep 2012N/ATBD

FY 2012 YTD: 26

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

Fiscal Year - 2012
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TimeTargetNumber
Oct 2011N/A0
Nov 2011N/A2
Dec 2011N/A0
Jan 2012N/ATBD
Feb 2012N/ATBD
Mar 2012N/ATBD
Apr 2012N/ATBD
May 2012N/ATBD
Jun 2012N/ATBD
Jul 2012N/ATBD
Aug 2012N/ATBD
Sep 2012N/ATBD

FY 2012 YTD: 2

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

Fiscal Year - 2012

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TimeTargetNumber
Oct 2011N/A0
Nov 2011N/A77
Dec 2011N/A0
Jan 2012N/ATBD
Feb 2012N/ATBD
Mar 2012N/ATBD
Apr 2012N/ATBD
May 2012N/ATBD
Jun 2012N/ATBD
Jul 2012N/ATBD
Aug 2012N/ATBD
Sep 2012N/ATBD

Number of overdue applications at the end of the month

Fiscal Year - 2012

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TimeTargetNumber
Oct 2011N/A3
Nov 2011N/A1
Dec 2011N/A1
Jan 2012N/ATBD
Feb 2012N/ATBD
Mar 2012N/ATBD
Apr 2012N/ATBD
May 2012N/ATBD
Jun 2012N/ATBD
Jul 2012N/ATBD
Aug 2012N/ATBD
Sep 2012N/ATBD

FY 2012 YTD: 5

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.