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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Veröffentlicht in:	Journal of clinical medicine 2021-06, Vol.10 (13), p.2878
Hauptverfasser:	Witkowski, Piotr, Odorico, Jon, Pyda, Jordan, Anteby, Roi, Stratta, Robert J, Schrope, Beth A, Hardy, Mark A, Buse, John, Leventhal, Joseph R, Cui, Wanxing, Hussein, Shakir, Niederhaus, Silke, Gaglia, Jason, Desai, Chirag S, Wijkstrom, Martin, Kandeel, Fouad, Bachul, Piotr J, Becker, Yolanda Tai, Wang, Ling-Jia, Robertson, R Paul, Olaitan, Oyedolamu K, Kozlowski, Tomasz, Abrams, Peter L, Josephson, Michelle A, Andreoni, Kenneth A, Harland, Robert C, Kandaswamy, Raja, Posselt, Andrew M, Szot, Gregory L, Ricordi, Camillo, On Behalf Of The Islets For Us Collaborative
Format:	Artikel
Sprache:	eng
Schlagworte:	Biological products Clinical medicine Clinical trials Collaboration Diabetes Drugs FDA approval Pancreas Patient safety Profits Transplants & implants
Online-Zugang:	Volltext
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