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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Detalles Bibliográficos
Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Commentary
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8269003/
https://www.ncbi.nlm.nih.gov/pubmed/34209541
http://dx.doi.org/10.3390/jcm10132878

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