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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, 2021

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.

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Number of Breakthrough Therapy Designation Withdrawn After Granting (WAG) and Rescinded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

Footnotes

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