FDA Clarifies and Expands Eligibility for RMAT Designation for Gene Therapies – Lexology
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FDA Clarifies and Expands Eligibility for RMAT Designation for Gene Therapies
Lexology Importantly, the draft guidance clarifies important aspects of the Regenerative Medicine Advanced Therapy (RMAT) designation established by the 21st Century Cures Act. In particular, the draft guidance expressly includes “gene therapies, including … |
