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, 2013.
Fiscal Year - 2012
FY 2012 3 month Total: 36
- 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.