Unproven stem cell industry in the U.S. : regulatory challenges and enforcement issues

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Abstract

Part I outlines the introduction of this article. Part 2 explains the methodology, which comprises literature review and expert interviews. Next, Part 3 describes the science of stem cells and the promise of these cells. This is followed by Part 4, which examines the ongoing concern about unproven stem cell treatments offered in the U.S. based on Turner’s recent study. Part 5. Assesses the enforcement of the law both at the federal and state levels; this includes warning letters and untitled letters issued, as well as various legal suits brought by multiple regulatory bodies against stem cell clinics. In Part 6, there is an examination of the different challenges FDA faces in its enforcement. Finally, Part 7 concludes with the recommendation that other regulators must play more significant roles in the enforcement measures against these unethical stem cells clinics to support FDA.
Original languageEnglish
Pages (from-to)184-198
Number of pages15
JournalBiotechnology Law Report
Volume42
Issue number4
DOIs
Publication statusPublished - 1 Aug 2023

Keywords

  • stem cells
  • FDA
  • law
  • regulation
  • enforcement

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