In (yet another) statement, FDA Commission Scott Gottlieb, M.D. announces the issuance of final updated guidance for gene therapy and cell therapy developers.
Under the Regenerative Medicine Advanced Therapy (RMAT) designation, qualified applications will be eligible for priority review and accelerated approval. Also, devices used with a specific RMAT will (together) be considered a combination product.
Draft guidance was released in November 2017.
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