Urgent Need for Regulatory Oversight of Human Cells, Tissues, and Cellular and Tissue-Based Products

JAMA. 2024 May 28;331(20):1703-1704. doi: 10.1001/jama.2024.6834.
No abstract available

Plain language summary

This Viewpoint discusses the death of a patient caused by unregulated biological products and efforts to encourage federal government oversight of such products.

Publication types

  • Case Reports

MeSH terms

  • Bone Transplantation* / adverse effects
  • Bone Transplantation* / standards
  • Bone and Bones* / microbiology
  • Bone and Bones* / surgery
  • Cell- and Tissue-Based Therapy / adverse effects
  • Cell- and Tissue-Based Therapy / standards
  • Disease Outbreaks*
  • Female
  • Government Regulation*
  • Humans
  • Middle Aged
  • Mycobacterium tuberculosis / isolation & purification
  • Tissue Banks / legislation & jurisprudence
  • Tissue Banks / standards
  • Tuberculosis* / epidemiology
  • Tuberculosis* / etiology
  • Tuberculosis* / microbiology
  • United States / epidemiology
  • United States Food and Drug Administration* / legislation & jurisprudence
  • United States Food and Drug Administration* / standards