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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

The US FDA’s newest expedited review program, the regenerative medicine advanced therapy (RMAT) designation, is gaining momentum after a slower ramp-up than the agency’s older breakthrough therapy designation (BTD), the Pink Sheet US FDA Performance Tracker shows.

Key Takeaways

  • 2024 is shaping up to be a banner year for the US FDA’s regenerative medicine advanced therapy designation with totals already exceeding the previous annual record for designations by more than one-third.

The FDA’s Center for Biologics Evaluation and Research has approved 11 novel biologics with an RMAT, starting with Bristol...

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