US FDA Grants RMAT Requests At Similar Rate To Breakthrough Designations

Over the first five years of the regenerative medicine advanced therapy designation, analysis by the Pink Sheet finds the 40% success rate of requests is comparable to the broader breakthrough therapy designation, despite less stringent RMAT criteria.

Regenerative medicine
RMAT designees are slower to receive full FDA approval than those with breakthrough therapy designations. • Source: Alamy

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