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Clarifying US regulations on xenotransplantation

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References

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  8. Executive Office of the President. Office of Science and Technology Policy. Coordinated Framework for Regulation of Biotechnology, 51 FR 23302, at 23302–23303 (June 26, 1986, 1986 Coordinated Framework). https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/2017_coordinated_framework_update.pdf (1986).

  9. Revivicor, Inc. Freedom of Information Summary. Original New Animal Drug Application NADA 141-542 pPL657: rDNA construct in domestic pigs. https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/10168 (2020).

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Authors and Affiliations

  1. Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA

    Peter Marks & Steven Solomon

  2. Center for Veterinary Medicine, US Food and Drug Administration, Rockville, MD, USA

    Peter Marks & Steven Solomon

Authors
  1. Peter Marks
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  2. Steven Solomon
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Correspondence to Peter Marks.

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The authors declare no competing interests.

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Marks, P., Solomon, S. Clarifying US regulations on xenotransplantation. Nat Biotechnol 39, 1500–1501 (2021). https://doi.org/10.1038/s41587-021-01144-7

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  • DOI: https://doi.org/10.1038/s41587-021-01144-7

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