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The US FDA’s newest expedited designation, Regenerative Medicine Advance Therapy (RMAT) status for certain biologics, has subtly different standards than the agency’s popular breakthrough therapy designation (BTD).

The graphic below highlights similarities and differences in the eligibility and evidentiary criteria and timelines for the two expedited regulatory pathways.


[Editor's note: readers may download the side-by-side comparison to keep on hand as a reference tool.]

Metrics to date suggest the success rates for designation requests under the BTD and RMAT programs are comparable despite the large difference in request volume between the two programs, which were created four years apart.(See charts.)



The Pink Sheet’s interactive FDA Performance Tracker keeps track of Breakthrough Therapy Designations, including evidence supporting the designation and current clinical status, and maintains a more detailed breakdown of requests.

RMAT totals were reported by FDA Office of Tissues and Advanced Therapies (OTAT) Director Wilson Bryan at the recent 2018 BIO International Convention. (Also see "RMAT Designation Requests May Rise Or Fall On Manufacturing Changes, Clinical Data Breadth" - Pink Sheet, 27 Jun, 2018.)

[Editor’s note: Should Pink Sheet add RMAT designations to the FDA Performance Tracker? Let us know your thoughts at]


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