U.S. flag An official website of the United States government
  1. Home
  2. Vaccines, Blood & Biologics
  3. Cellular & Gene Therapy Products
  4. Cumulative CBER Regenerative Medicine Advanced Therapy (RMAT) Designation Requests Received by Fiscal Year
  1. Cellular & Gene Therapy Products

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

Cohort: December 13, 2016 - September 30, 2024

Data as of December 31, 2023

Fiscal Year

Total Requests
Received

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Withdrawn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 17 18 0
2024 10 2 4 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.


Resources for You

 
Back to Top