Cumulative CBER Regenerative Medicine Advanced Therapy (RMAT) Designation Requests Received by Fiscal Year
Cohort: December 13, 2016 - September 30, 2025
Data as of March 31, 2025
Fiscal Year | Total Requests | Granted | Denied | Withdrawn |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 | 9 | 13 | 2 |
| 2022 | 30 | 14 | 15 | 1 |
| 2023 | 35 | 18 | 17 | 0 |
| 2024 | 59 | 43 | 14 | 2 |
| 2025 | 45 | 24 | 5 | 3 |
* 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.