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, 2025

Data as of March 31, 2025

Fiscal Year

Total Requests
Received

Granted

Denied

Withdrawn

20173111182
20184718272
20193717182
20203413210
2021249132
20223014151
20233518170
20245943142
2025452453

* 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