Practical Insights for Cell and Gene Therapy Long-term Follow-up Studies

9 Pages

This insight brief focuses on regulatory strategies for cell and gene therapies (CAGTs) submitted to the FDA. It discusses the unique challenges of CAGT development, including small patient populations, long-term safety requirements, and evolving regulatory expectations. The brief emphasizes the importance of early engagement, robust evidence generation, and long-term follow-up planning. IQVIA highlights how real-world data, registries, and innovative study designs can support regulatory decision-making and lifecycle management for advanced therapies.

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Practical Insights for Cell and Gene Therapy Long-term Follow-up Studies

Practical Insights for Cell and Gene Therapy Long-term Follow-up Studies

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