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dc.contributor.authorWitkowski, Piotr
dc.contributor.authorOdorico, Jon
dc.contributor.authorPyda, Jordan
dc.contributor.authorAnteby, Roi
dc.contributor.authorStratta, Robert J
dc.contributor.authorSchrope, Beth A
dc.contributor.authorHardy, Mark A
dc.contributor.authorBuse, John
dc.contributor.authorLeventhal, Joseph R
dc.contributor.authorCui, Wanxing
dc.contributor.authorHussein, Shakir
dc.contributor.authorNiederhaus, Silke
dc.contributor.authorGaglia, Jason
dc.contributor.authorDesai, Chirag S
dc.contributor.authorWijkstrom, Martin
dc.contributor.authorKandeel, Fouad
dc.contributor.authorBachul, Piotr J
dc.contributor.authorBecker, Yolanda Tai
dc.contributor.authorWang, Ling-Jia
dc.contributor.authorRobertson, R Paul
dc.contributor.authorOlaitan, Oyedolamu K
dc.contributor.authorKozlowski, Tomasz
dc.contributor.authorAbrams, Peter L
dc.contributor.authorJosephson, Michelle A
dc.contributor.authorAndreoni, Kenneth A
dc.contributor.authorHarland, Robert C
dc.contributor.authorKandaswamy, Raja
dc.contributor.authorPosselt, Andrew M
dc.contributor.authorSzot, Gregory L
dc.contributor.authorRicordi, Camillo
dc.contributor.authorOn Behalf Of The Islets For Us Collaborative
dc.date.accessioned2021-07-12T13:59:43Z
dc.date.available2021-07-12T13:59:43Z
dc.date.issued2021-06-29
dc.identifier.urihttp://hdl.handle.net/10713/16168
dc.description.abstractThe 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 development of the field for the last 20 years. Herein, we provide our commentary to the multiple FDA's position papers and guidance for industry arguing that BLA requirement has been inappropriately applied to allogeneic islets, which was delivered to the FDA Cellular, Tissue and Gene Therapies Advisory Committee on 15 April 2021. We provided evidence that BLA requirement and drug related regulations are inadequate in reassuring islet product quality and potency as well as patient safety and clinical outcomes. As leaders in the field of transplantation and endocrinology under the "Islets for US Collaborative" designation, we examined the current regulatory status of islet transplantation in the US and identified several anticipated negative consequences of the BLA approval. In our commentary we also offer an alternative pathway for islet transplantation under the regulatory framework for organ transplantation, which would address deficiencies of in current system.en_US
dc.description.urihttps://doi.org/10.3390/jcm10132878en_US
dc.language.isoenen_US
dc.publisherMDPI AGen_US
dc.relation.ispartofJournal of Clinical Medicineen_US
dc.subjectFood and Drug Administrationen_US
dc.subjectallogenic islet cell transplantationen_US
dc.subjectpancreasen_US
dc.titleArguments 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 Meetingen_US
dc.typeArticleen_US
dc.identifier.doi10.3390/jcm10132878
dc.identifier.pmid34209541
dc.source.volume10
dc.source.issue13
dc.source.countrySwitzerland


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