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U.S. Department of Health and Human Services

About FDA

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Number of Breakthrough Therapy Designation Requests Received

Dictionary: These processes are reserved for submissions that are intended to treat serious or life threatening condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies, and to facilitate the development and expedite the review of products that demonstrate the potential to address unmet medical needs. All requests for breakthrough therapy designation will be reviewed within 60 days of receipt.

Information is current as of September 30, 2017

Fiscal Year - 2017

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TimeTargetNumber
October – December 2016N/A12
January – March 2017N/A5
April – June 2017N/A4
July – September 2017N/A4

FY 2017 Total: 25

Footnotes

  • (1) CBER created new measures and began collecting data in April 2015. Therefore, FY15 will only include third and fourth quarter data

Number of Breakthrough Therapy Designation Approvals

Dictionary: These processes are reserved for submissions that are intended to treat serious or life threatening diseases, and to facilitate the development and expedite the review of products that demonstrate the potential to address unmet medical needs. When a drug and its intended use has been granted breakthrough therapy designation, FDA will expedite the development and review of such drug.

Fiscal Year - 2017

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TimeTargetNumber
October – December 2016N/A3
January – March 2017N/A2
April – June 2017N/A2
July – September 2017N/A1

FY 2017 Total: 8

Footnotes

  • (1) CBER created new measures and began collecting data in April 2015. Therefore, FY15 will only include third and fourth quarter data

Number of Breakthrough Therapy Designation Withdrawn After Granting (WAG) and Rescinded

Dictionary: These processes are reserved for submissions that are intended to treat serious or life threatening diseases, and to facilitate the development and expedite the review of products that demonstrate the potential to address unmet medical needs. All requests for breakthrough therapy designation will be reviewed within 60 days of receipt. FDA will either grant or deny the request. FDA reserves the right to rescind the designation if subsequent evidence demonstrates that the therapy no longer meets the criteria or the program is no longer being pursued. The Sponsor reserves the right to, post FDA’s granting of the designation, request for withdrawal of the designation.

Fiscal Year - 2017

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TimeTargetNumber
October – December 2016N/A0
January – March 2017N/A0
April – June 2017N/A0
July – September 2017N/A0

FY 2017 Total: 0

Footnotes

  • (1) CBER created new measures and began collecting data in April 2015. Therefore, FY15 will only include third and fourth quarter data

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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