US food and drug administration (FDA) panel endorses islet cell treatment for type 1 diabetes: A pyrrhic victory?
European medicines agency
food and drug administration
pancreatic islet transplantation
regulatory authorities
Journal
Transplant international : official journal of the European Society for Organ Transplantation
ISSN: 1432-2277
Titre abrégé: Transpl Int
Pays: Switzerland
ID NLM: 8908516
Informations de publication
Date de publication:
07 2021
07 2021
Historique:
received:
05
05
2021
accepted:
24
05
2021
pubmed:
29
5
2021
medline:
3
8
2021
entrez:
28
5
2021
Statut:
ppublish
Résumé
Allogeneic islet transplantation is a standard of care treatment for patients with labile type 1 diabetes in many countries around the world, including Japan, the United Kingdom, Australia, much of continental Europe, and parts of Canada. The United States is now endorsing islet cell treatment for type 1 diabetes, but the FDA has chosen to consider islets as a biologic that requires licensure, making the universal implementation of the procedure in the clinic very challenging and opening the manufacture of islet grafts to private companies. The commercialization of human tissues raises significant legal and ethical issues and ironically leads to a situation where treatments developed as a result of the scientific and economic efforts of academia over several decades become exploited exclusively by for-profit entities.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1182-1186Informations de copyright
© 2021 Steunstichting ESOT. Published by John Wiley & Sons Ltd.
Références
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