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Imaging, invasive diagnostics, and minor surgical procedures on pediatric patients outside the operating room setting have increased, and there is a need for sedatives that have been properly assessed in the pediatric population for this indication. This chapter will review the process of obtaining FDA approval of a drug or biologic for use in pediatric patients with a focus on sedation.

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Pediatric Sedatives and the Food and Drug Administration: Challenges, Limitations, and Drugs in Development

  • 章节

  • 发表日期：

    2025年

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  • Lily Yeruk Mulugeta,
  • Lisa L. Bollinger,
  • Lynne P. Yao

摘要

Imaging, invasive diagnostics, and minor surgical procedures on pediatric patients outside the operating room setting have increased, and there is a need for sedatives that have been properly assessed in the pediatric population for this indication. This chapter will review the process of obtaining FDA approval of a drug or biologic for use in pediatric patients with a focus on sedation.