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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 March 31, 2014.

Fiscal Year - 2014

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TimeTargetNumber
Oct 2013N/A14
Nov 2013N/A9
Dec 2013N/A17
Jan 2014N/A9
Feb 2014N/A8
Mar 2014N/A10
Apr 2014N/ATBD
May 2014N/ATBD
Jun 2014N/ATBD
Jul 2014N/ATBD
Aug 2014N/ATBD
Sep 2014N/ATBD

FY 2014 YTD: 67

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 - 2014

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TimeTargetNumber
Oct 2013N/A13
Nov 2013N/A8
Dec 2013N/A7
Jan 2014N/A6
Feb 2014N/A3
Mar 2014N/A12
Apr 2014N/ATBD
May 2014N/ATBD
Jun 2014N/ATBD
Jul 2014N/ATBD
Aug 2014N/ATBD
Sep 2014N/ATBD

FY 2014 YTD: 49

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 - 2014
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TimeTargetNumber
Oct 2013N/A12
Nov 2013N/A7
Dec 2013N/A5
Jan 2014N/A4
Feb 2014N/A2
Mar 2014N/A10
Apr 2014N/ATBD
May 2014N/ATBD
Jun 2014N/ATBD
Jul 2014N/ATBD
Aug 2014N/ATBD
Sep 2014N/ATBD

FY 2014 YTD: 40

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.