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dc.contributor.authorWitkowski, Piotr
dc.contributor.authorAnteby, Roi
dc.contributor.authorOlaitan, Oyedolamu K
dc.contributor.authorForbes, Racheal C
dc.contributor.authorNiederhaus, Silke
dc.contributor.authorRicordi, Camilo
dc.contributor.authorFair, Jeffrey H
dc.contributor.authorHarland, Robert C
dc.date.accessioned2021-12-13T17:26:44Z
dc.date.available2021-12-13T17:26:44Z
dc.date.issued2021-12
dc.identifier.urihttp://hdl.handle.net/10713/17361
dc.description.urihttps://doi.org/10.1097/TP.0000000000003880en_US
dc.language.isoenen_US
dc.publisherWolters Kluwer Healthen_US
dc.relation.ispartofTransplantationen_US
dc.subjectbiologic license application (BLA)en_US
dc.subjectOPTN Final Ruleen_US
dc.subject.lcshUnited States. Food and Drug Administrationen_US
dc.subject.meshIslets of Langerhans Transplantation--standardsen_US
dc.titlePancreatic Islets Quality and Potency Cannot be Verified as Required for Drugs: Reflection on the FDA Review of a Biological License Application for Human Isletsen_US
dc.typeArticleen_US
dc.identifier.doi10.1097/TP.0000000000003880
dc.identifier.pmid34231527
dc.source.volume105
dc.source.issue12
dc.source.beginpagee409
dc.source.endpagee410
dc.source.countryUnited States


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