MainNumber of Breakthrough Therapy Designation Requests ReceivedThese 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. <i>Information is current as of September 30, 2021</i>(1) CBER created new measures and began collecting data in April 2015. Therefore, FY15 will only include third and fourth quarter dataNumbercolumn02015FY 2015 Total: 702016FY 2016 Total: 2302017FY 2017 Total: 2502018FY 2018 Total: 1802019FY 2019 Total: 192020FY 2020 Total: 132021FY 2021 Total: 9MainNumber of Breakthrough Therapy Designation ApprovalsThese 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.(1) CBER created new measures and began collecting data in April 2015. Therefore, FY15 will only include third and fourth quarter dataNumbercolumn02015FY 2015 Total: 102016FY 2016 Total: 402017FY 2017 Total: 802018FY 2018 Total: 902019FY 2019 Total: 82020FY 2020 YTD: 42021FY 2021 Total: 4MainNumber of Breakthrough Therapy Designation Withdrawn After Granting (WAG) and RescindedThese processes are reserved for submissions that are intended to treat serious or life threatening diseases, and to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. (1) CBER created new measures and began collecting data in April 2015. Therefore, FY15 will only include third and fourth quarter dataNumbercolumn02015FY 2015 Total: 102016FY 2016 Total: 002017FY 2017 Total: 002018FY 2018 Total: 002019FY 2019 Total: 02020FY 2020 Total: 02021FY 2021 Total: 0http://www.fda.gov/AboutFDA/Transparency/track/ucm206804.htmFDA-TRACK CBER Dashboardword textword defintion