Cumulative CBER Regenerative Medicine Advanced Therapy (RMAT) Designation Requests Received by Fiscal Year
Cohort: December 13, 2016 - September 30, 2022
Data as of December 31, 2021
|
Fiscal Year |
Total Requests |
Granted |
Denied |
Withdrawn |
|---|---|---|---|---|
| 2017 | 31 | 11 | 18 | 2 |
| 2018 | 47 | 18 | 27 | 2 |
| 2019 | 37 | 17 | 18 | 2 |
| 2020 | 34 | 13 | 21 | 0 |
| 2021 | 24 | 7 | 15 | 2 |
| 2022 | 7 | 2 | 1 | 0 |
* 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.