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U.S. Department of Health and Human Services

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Number of New Drug Applications (NDAs) and Biologics License Applications (BLAs) submitted

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

Information is current as of September 30, 2014.

Fiscal Year - 2013

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TimeTargetNumber
Oct 2012N/A11
Nov 2012N/A5
Dec 2012N/A18
Jan 2013N/A7
Feb 2013N/A10
Mar 2013N/A12
Apr 2013N/A11
May 2013N/A12
Jun 2013N/A10
Jul 2013N/A9
Aug 2013N/A7
Sep 2013N/A21

FY 2013 Total: 133

Footnotes

  • CDER created new measures and began collecting data in July 2012. Therefore, FY12 will only include 3 months of data.

Number of New Drug Applications (NDAs) and Biologics License Applications (BLAs) approved

Fiscal Year - 2013

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TimeTargetNumber
Oct 2012N/A10
Nov 2012N/A6
Dec 2012N/A15
Jan 2013N/A11
Feb 2013N/A9
Mar 2013N/A9
Apr 2013N/A8
May 2013N/A8
Jun 2013N/A3
Jul 2013N/A8
Aug 2013N/A7
Sep 2013N/A2

FY 2013 Total: 96

Footnotes

  • CDER created new measures and began collecting data in July 2012. Therefore, FY12 will only include 3 months of data.

Number of New Drug Applications (NDAs) and Biologics License Applications (BLAs) approved within the first cycle in the month

Fiscal Year - 2013
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TimeTargetNumber
Oct 2012N/A7
Nov 2012N/A2
Dec 2012N/A9
Jan 2013N/A9
Feb 2013N/A7
Mar 2013N/A5
Apr 2013N/A8
May 2013N/A6
Jun 2013N/A3
Jul 2013N/A7
Aug 2013N/A2
Sep 2013N/A1

FY 2013 Total: 66

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.