US FDA Grants RMAT Requests At Similar Rate To Breakthrough Designations

The US Food and Drug Administration's Regenerative Medicine Advanced Therapy (RMAT) designation for innovative biologics has never had the cachet of the slightly older Breakthrough Therapy designation (BTD), but FDA data on RMAT requests, as well as FDA decisions, are following a similar trajectory to the early years of BTD.

But while the FDA grants and denies BTD and RMAT requests in generally proportionate ways, on one of the most significant outcomes, eventual FDA approval, the regenerative medicine pipeline is more sluggish