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U.S. Department of Health and Human Services

About FDA

Number of NDA and BLA efficacy supplements submitted

Dictionary: Efficacy Supplements to NDAs and BLAs are applications to make certain changes (e.g., add a new indication) to an approved marketing application. These supplements have legislatively mandated timelines for review.

Information is current as of March 31, 2015.

Fiscal Year - 2014

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Oct 2013N/A11
Nov 2013N/A12
Dec 2013N/A24
Jan 2014N/A9
Feb 2014N/A11
Mar 2014N/A12
Apr 2014N/A15
May 2014N/A20
Jun 2014N/A9
Jul 2014N/A15
Aug 2014N/A18
Sep 2014N/A17

FY 2014 Total: 173


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


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.