Arguments against the Requirement of a Biological License Application for Human Pancreatic Islets: The Position Statement of the Islets for US Collaborative Presented during the FDA Advisory Committee Meeting

Autor: Kenneth A. Andreoni, Beth Schrope, Robert C. Harland, R. Paul Robertson, John B. Buse, Ling-Jia Wang, Jordan Pyda, Oyedolamu K. Olaitan, Yolanda T. Becker, Mark A. Hardy, Roi Anteby, Gregory L. Szot, Piotr Witkowski, Piotr J. Bachul, Chirag S. Desai, Jon S. Odorico, Silke V. Niederhaus, Martin Wijkstrom, Fouad Kandeel, Raja Kandaswamy, Michelle A. Josephson, Tomasz Kozlowski, Peter L. Abrams, Jason L. Gaglia, Joseph R. Leventhal, Wanxing Cui, Shakir Hussein, Camillo Ricordi, Andrew M. Posselt, Robert J. Stratta

Publikováno v: Journal of clinical medicine, vol 10, iss 13
Journal of Clinical Medicine
Journal of Clinical Medicine, Vol 10, Iss 2878, p 2878 (2021)

The Food and Drug Administration (FDA) has been regulating human islets for allotransplantation as a biologic drug in the US. Consequently, the requirement of a biological license application (BLA) approval before clinical use of islet transplantatio

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::649fe399a90d397c08b684c080c26a6a
https://escholarship.org/uc/item/1236c9p6

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