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

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Pediatric Sedation Outside of the Operating Room

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Abstract

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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Notes

  1. 1.

    For the purposes of this chapter, future references to the term “drug” will include both drug and biologic products.

  2. 2.

    Biologics Licensing Application (BLA) and supplement Biologics Licensing Application (sBLA) are submitted for biological products.

  3. 3.

    Under the RACE for Children Act (Research to Accelerate Cures and Equity for Children Act), passed by Congress in 2017, PREA was amended to remove the exemption for orphan-designated drugs being developed to treat adult cancers with molecular targets substantially relevant to pediatric cancers.

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Author information

Authors and Affiliations

  1. Global Patient Safety and Pediatrics, Global Regulatory Affairs and Safety, Amgen Inc, Thousand Oaks, CA, USA

    Lisa L. Bollinger

  2. Division of Pediatric and Maternal Health, Office of New Drugs, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, USA

    Lynne P. Yao

Authors
  1. Lisa L. Bollinger
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  2. Lynne P. Yao
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Corresponding author

Correspondence to Lynne P. Yao .

Editor information

Editors and Affiliations

  1. Department of Anesthesiology, Harvard Medical School, Boston, MA, USA

    Keira P. Mason, MD

Additional information

Disclaimer The views expressed herein represent those of the authors and do not necessarily represent the views or practices of the authors’ employers or any other party. No official support or endorsements by the US Food and Drug Administration are provided or should be inferred. No commercial interest or other conflict of interest exists between L. Yao and the pharmaceutical companies. L. Bollinger is employed by Amgen, Inc.

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Bollinger, L.L., Yao, L.P. (2021). Pediatric Sedatives and the Food and Drug Administration (FDA): Challenges, Limitations, and Drugs in Development. In: Mason, MD, K.P. (eds) Pediatric Sedation Outside of the Operating Room. Springer, Cham. https://doi.org/10.1007/978-3-030-58406-1_32

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  • DOI: https://doi.org/10.1007/978-3-030-58406-1_32

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  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-030-58405-4

  • Online ISBN: 978-3-030-58406-1

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