Regenerative Medicine Advanced Therapy (RMAT) Designation

Published by IRDiRC

Regulatory AffairsEarly Access SupportAdvanced TherapyRegenerative Medicine Advanced Therapy Designation

The RMAT Designation is analogous to the Breakthrough Designation designed for traditional drug candidates but applies to regenerative medicine treatments, and allows companies to interact with the FDA more frequently during the clinical development of the therapy. An RMAT-designated therapy is eligible for priority review and accelerated approval.

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