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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 December 31, 2014.

Fiscal Year - 2015

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TimeTargetNumber
Oct 2014N/A9
Nov 2014N/A16
Dec 2014N/A11
Jan 2015N/ATBD
Feb 2015N/ATBD
Mar 2015N/ATBD
Apr 2015N/ATBD
May 2015N/ATBD
Jun 2015N/ATBD
Jul 2015N/ATBD
Aug 2015N/ATBD
Sep 2015N/ATBD

FY 2015 YTD: 36

Footnotes

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

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.