The definition of accessibility may influence whether the US Food and Drug Administration would consider efficacy concessions on a CAR-T treatment if the product were more easily available to patients than current options.
Key Takeaways
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FDA considers access in the context of unmet need in its regulatory decisions.
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The reach of CAR-T therapy currently is limited by a range of access challenges, including high cost, geographical limitations for administration, and manufacturing complexities
Access is not necessarily a part of FDA’s regulatory framework per se, but the agency does consider unmet need, Lola Fashoyin-Aje, director of the Office of Clinical Evaluation for cellular, tissue and gene therapies in the Center for Biologics Evaluation and
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