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U.S. Department of Health and Human Services

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FDA-TRACK Home Page or Center for Biologics Evaluation and Research Index

Number of Fast track designations granted 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. Fast track designation is intended to facilitate the development, and expedite the review of a product to treat serious or life-threatening conditions, and nonclinical or clinical data demonstrate the potential to address an unmet medical need.

Information is current as of September 30, 2021

Fiscal Year - 2021

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TimeTargetNumber
Oct - Dec 2020N/A15
Jan - Mar 2021N/A15
Apr - Jun 2021N/A2
Jul - Sept 2021N/A13

FY 2021 Total: 45

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.
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