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The Regulatory Review of Radiotherapeutics: United States of America

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Radiopharmaceutical Therapy

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Abstract

Therapeutic radiopharmaceuticals possess unique characteristics that warrant special consideration from the regulatory entities that govern the development and human use of this class of drugs. Indeed, factors such as their short shelf-life, small batch size, and emission of toxic ionizing radiation all have a major impact on the requirements governing the production, analytical testing, handling, administration, and waste management of radiotherapeutics. This chapter is intended to introduce the reader to the general regulatory landscape covering the development and clinical use of therapeutic radiopharmaceuticals in the United States of America.

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References

  1. United States Food and Drug Administration. Oncology therapeutic radiopharmaceuticals: nonclinical studies and labeling recommendations guidance to industry; 2019.

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Author information

Authors and Affiliations

  1. Department of Radiology, Memorial Sloan Kettering Cancer Center, New York City, NY, USA

    Serge K. Lyashchenko

Authors
  1. Serge K. Lyashchenko
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Correspondence to Serge K. Lyashchenko .

Editor information

Editors and Affiliations

  1. Memorial Sloan Kettering Cancer Center, New York, NY, USA

    Lisa Bodei

  2. Memorial Sloan Kettering Cancer Center, New York, NY, USA

    Jason S. Lewis

  3. Hunter College - CUNY, New York, NY, USA

    Brian M. Zeglis

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© 2023 The Author(s), under exclusive license to Springer Nature Switzerland AG

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Lyashchenko, S.K. (2023). The Regulatory Review of Radiotherapeutics: United States of America. In: Bodei, L., Lewis, J.S., Zeglis, B.M. (eds) Radiopharmaceutical Therapy. Springer, Cham. https://doi.org/10.1007/978-3-031-39005-0_25

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  • DOI: https://doi.org/10.1007/978-3-031-39005-0_25

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  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-031-39004-3

  • Online ISBN: 978-3-031-39005-0

  • eBook Packages: Biomedical and Life Sciences

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