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

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

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 transplantation as a standard of care procedure has stalled the...

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Bibliographic Details
Main Authors: Piotr Witkowski, Jon Odorico, Jordan Pyda, Roi Anteby, Robert J. Stratta, Beth A. Schrope, Mark A. Hardy, John Buse, Joseph R. Leventhal, Wanxing Cui, Shakir Hussein, Silke Niederhaus, Jason Gaglia, Chirag S. Desai, Martin Wijkstrom, Fouad Kandeel, Piotr J. Bachul, Yolanda Tai Becker, Ling-Jia Wang, R. Paul Robertson, Oyedolamu K. Olaitan, Tomasz Kozlowski, Peter L. Abrams, Michelle A. Josephson, Kenneth A. Andreoni, Robert C. Harland, Raja Kandaswamy, Andrew M. Posselt, Gregory L. Szot, Camillo Ricordi, on behalf of the Islets for US Collaborative
Format: Article
Language:English
Published: MDPI AG 2021-06-01
Series:Journal of Clinical Medicine
Subjects:
allogenic islet cell transplantation
pancreas
Food and Drug Administration
Online Access:https://www.mdpi.com/2077-0383/10/13/2878

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https://www.mdpi.com/2077-0383/10/13/2878

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