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The agency clarified the process for development programs for regenerative medicine therapies.
FDA provided further details in February 2019 on how manufacturers may use expedited development programs for regenerative medicine therapies, clarifying that the category includes gene and Chimeric antigen receptor T cells (CAR-T) therapies, as well as cellular and tissue products. These innovative treatments may qualify for breakthrough status and the regenerative medicine advanced therapy (RMAT) designation, if found to treat serious or life-threatening conditions that lack current treatment.
The guidance from the Center for Biologics Evaluation and Research (CBER) outlines the process for qualifying for RMAT status and what evidence is necessary to gain the designation. CBER encourages product sponsors to engage review staff early in development to discuss issues related to pharmacology and manufacturing, as well as pre-clinical and clinical trial approaches.
In addition, a second guidance discusses a range of medical devices that may be used in conjunction with a regenerative medicine product. This may include low-risk surgical instruments for recovering cells and tissue, or more complex cell collection and processing systems. The document clarifies current premarket development pathways and when a device and regenerative medicine could be considered a combination product.