FDA Clarifies and Expands Eligibility for RMAT Designation for Gene Therapies

On November 16, in the context of announcing a comprehensive regenerative medicine policy framework (discussed here), FDA released a draft guidance document that describes the expedited programs available for the development and review of certain regenerative medicine therapies.  Importantly, the draft guidance clarifies certain aspects of the Regenerative Medicine Advanced Therapy (RMAT) designation established by the 21st Century Cures Act.  In particular, the draft guidance expressly includes “gene therapies, including genetically modified cells, that lead to a durable modification of cells or tissues” in FDA’s interpretation of a “regenerative medicine therapy” that may be eligible for RMAT designation.

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