Slow Burn: US FDA RMAT Designations Surge While Breakthrough Pace Softens

 
• By Bridget Silverman

The US FDA’s regenerative medicine advanced therapy designation is seeing its biggest year yet after a slower ramp-up than the more established breakthrough therapy pathway.

data increasing
RMAT designations are growing while Breakthrough Therapy designations appear to have passed their peak, according to Pink Sheet data. • Source: Shutterstock

More from US FDA Performance Tracker

More from Regulatory Trackers