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Cumulative CBER Regenerative Medicine Advanced Therapy (RMAT) Designation Requests Received by Fiscal Year

Cumulative CBER Regenerative Medicine Advanced Therapy (RMAT) Designation Requests Received by Fiscal Year

Cohort: December 13, 2016 - September 30, 2019

Data as of June 30, 2019

Fiscal Year

Total Requests
Received

Granted

Denied

Withdrawn

2017 31 11 18 2
2018 47 18 27 2
2019 30 11 13 1

* RMAT designation was enacted in the 21st Century Cures Act on December 13, 2016.
* Requests that are still pending a decision are included in the total requests received column.


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