The Regenerative Medicine Advanced Therapy (RMAT) designation is a critical regulatory pathway established by the U.S. Food and Drug Administration (FDA) under the 21st Century Cures Act. This designation is designed to expedite the development and approval of regenerative medicine products that show promise in treating, modifying, reversing, or curing serious or life-threatening diseases or conditions. In this article, we will explore the key aspects of the RMAT designation, including the types of products that qualify, the historical context, the scientific foundation, regulatory implications, and the associated costs of pursuing this designation.
Understanding the RMAT Designation: A Pathway for Regenerative Medicine Products
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