Number of orphan drugs addressing rare diseases approved in the quarter
Dictionary: These processes are reserved for submissions that are intended to treat serious or life-threatening conditions, and to facilitate the development and expedite the review of biologics that demonstrate the potential to address unmet medical needs.
Information is current as of March 31, 2015
Fiscal Year - 2014
|October – December 2013||N/A||4|
|January – March 2014||N/A||4|
|April – June 2014||N/A||1|
|July – September 2014||N/A||2|
FY 2014 Total: 11
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.