The Center for Biologics Evaluation and Research (CBER) recently updated web pages that track Regenerative Medicine Advanced Therapy (RMAT) designation requests, approvals and withdrawals. As described in Section 3033 of the 21st Century Cures Act, a drug is eligible for RMAT designation if it meets the following criteria:
- The drug is a regenerative medicine therapy (defined as a cellular therapy, therapeutic tissue engineering product, human cell and tissue product or any combination product using such therapies or products, except for those regulated solely under Section 361 of the Public Health Service Act and part 1271 of Title 21, Code of Federal Regulations).
- The drug is intended to treat, modify, reverse or cure a serious or life-threatening disease or condition.
- Preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such disease or condition.
