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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 September 30, 2014.

Fiscal Year - 2012

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TimeTargetNumber
Oct 2011N/AN/A
Nov 2011N/AN/A
Dec 2011N/AN/A
Jan 2012N/AN/A
Feb 2012N/AN/A
Mar 2012N/AN/A
Apr 2012N/AN/A
May 2012N/AN/A
Jun 2012N/AN/A
Jul 2012N/A15
Aug 2012N/A15
Sep 2012N/A6

FY 2012 3 month Total: 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.