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Sponsored Artificial Intelligence: A Modern Approach, Global Edition Artificial Intelligence: A Modern Approach, Global Edition

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Yasuyuki Takashima

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Review Open access Sep 2026

Addressing Efficacy Uncertainties in Expedited Programs for Gene Therapy Products: A Comparative Assessment of Post-Approval Requirements by the FDA and EMA

Expedited programs accelerate the availability of gene therapy products but frequently leave uncertainties regarding efficacy at approval. How post-approval requirements are utilized to complement these specific evidence gaps remains unclear. To address this, we conducted a detailed analysis of 18 gene therapy products...

Kimika Nakamura, Yasuyuki Takashima, Shinya Watanabe et al. · 0 citations

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