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U.S. Department of Health and Human Services

About FDA

Number of applications approved under Accelerated Approval 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. Accelerated Approval is the study of a product for safety and effectiveness in treating serious or life-threatening illness and that provides benefit over existing treatments.

Information is current as of December 31, 2014

Fiscal Year - 2015

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October – December 2014N/A2
January – March 2015N/ATBD
April – June 2015N/ATBD
July – September 2015N/ATBD

FY 2015 YTD: 2


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.