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

Number of priority reviews 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. Priority Review means that the time it takes FDA to review a new drug application is reduced. The goal for completing a Priority Review is six months.

Information is current as of September 30, 2021

Fiscal Year - 2021

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TimeTargetNumber
Oct - Dec 2020N/A2
Jan - Mar 2021N/A3
Apr - Jun 2021N/A3
Jul - Sept 2021N/A3

FY 2021 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.
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