Posted by Michael Wonder on 19 Feb 2018
RMAT vs. breakthrough vs. fast track: companies seek clarity on FDA draft guidance
19 February 2018 - Industry groups BIO, the Alliance for Regenerative Medicine and the International Society for Cellular Therapy, as well as biopharma companies Gilead and Biocom, are seeking clarity from the US FDA on guidance related to its relatively new Regenerative Medicine Advanced Therapy designation, according to comments submitted last week.
The 21st Century Cures Act created the Regenerative Medicine Advanced Therapy (RMAT) designation to speed the review of cell therapies, therapeutic tissue engineering products, human cell and tissue products or any combination product using such therapies or products if it “is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition” and “preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such disease or condition.”
Hailed as a way to speed such regenerative treatments to US patients in need, the designation has already been sought by dozens of companies as Peter Marks, director of FDA's Center for Biologics Evaluation and Research, said in November that the agency had received 34 RMAT designation requests, acted on 31 requests and granted 11 RMAT designations.
