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U.S. Department of Health and Human Services

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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 January 31, 2014

Fiscal Year - 2013

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TimeTargetNumber
October – December 2012N/A0
January – March 2013N/A3
April – June 2013N/A2
July – September 2013N/A0

FY 2013 Total: 5

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.