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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.
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.
Afiliação
  • Witkowski P; Transplantation Institute, Department of Surgery, University of Chicago, Chicago, IL 60637, USA.
  • Odorico J; Division of Transplantation, Department of Surgery, University of Wisconsin, School of Medicine and Public Health, Madison, WI 53792, USA.
  • Pyda J; Beth Israel Deaconess Medical Center, Department of Surgery, Harvard Medical School, Boston, MA 02115, USA.
  • Anteby R; Harvard T.H. Chan School of Public Health, Boston, MA 02115, USA.
  • Stratta RJ; Faculty of Medicine, Tel Aviv University, Tel Aviv 69978, Israel.
  • Schrope BA; Section of Transplantation, Department of Surgery, Wake Forest School of Medicine, Winston-Salem, NC 27101, USA.
  • Hardy MA; Department of Surgery, Columbia University College of Physicians and Surgeons, New York, NY 10032, USA.
  • Buse J; Department of Surgery, Columbia University College of Physicians and Surgeons, New York, NY 10032, USA.
  • Leventhal JR; Division of Endocrinology, Department of Medicine, University of NC, Chapel Hill, NC 27516, USA.
  • Cui W; Department of Surgery, Northwestern University School of Medicine, Chicago, IL 60611, USA.
  • Hussein S; Cell Therapy Manufacturing Facility, Georgetown University Hospital, Washington, DC 20007, USA.
  • Niederhaus S; Detroit Medical Center, Department of Surgery, Wayne State School of Medicine, Detroit, MI 48201, USA.
  • Gaglia J; Department of Surgery, University of Maryland School of Medicine, Baltimore, MD 21201, USA.
  • Desai CS; Joslin Diabetes Center, Harvard Medical School, Boston, MA 02215, USA.
  • Wijkstrom M; Department of Surgery, Section of Transplantation, University of NC, Chapel Hill, NC 27516, USA.
  • Kandeel F; Department of Surgery, University of Pittsburgh, Pittsburgh, PA 15260, USA.
  • Bachul PJ; Department of Translational Research and Cellular Therapeutics, Diabetes and Metabolism Research Institute, Beckman Research Institute of City of Hope, Duarte, CA 91010, USA.
  • Becker YT; Transplantation Institute, Department of Surgery, University of Chicago, Chicago, IL 60637, USA.
  • Wang LJ; Transplantation Institute, Department of Surgery, University of Chicago, Chicago, IL 60637, USA.
  • Robertson RP; Transplantation Institute, Department of Surgery, University of Chicago, Chicago, IL 60637, USA.
  • Olaitan OK; Division of Endocrinology and Metabolism, Department of Internal Medicine, University of Washington, Seattle, WA 98133, USA.
  • Kozlowski T; Department of Surgery, Rush University Medical Center, Chicago, IL 60612, USA.
  • Abrams PL; Division of Transplantation, Department of Surgery, The University of Oklahoma College of Medicine, Oklahoma City, OK 73104, USA.
  • Josephson MA; MedStar Georgetown Transplant Institute, Washington, DC 20007, USA.
  • Andreoni KA; Department of Medicine, University of Chicago, Chicago, IL 60637, USA.
  • Harland RC; Department of Surgery, University of Florida, College of Medicine, Gainesville, FL 32610-0118, USA.
  • Kandaswamy R; Case Western Reserve University, Cleveland, OH 44106-5047, USA.
  • Posselt AM; Department of Surgery, University of Arizona, Tucson, AZ 85711, USA.
  • Szot GL; Department of Surgery, University of Minnesota, Minneapolis, MN 55455, USA.
  • Ricordi C; Division of Transplantation, Department of Surgery, University of California San Francisco, San Francisco, CA 94143, USA.
  • On Behalf Of The Islets For Us Collaborative; Division of Transplantation, Department of Surgery, University of California San Francisco, San Francisco, CA 94143, USA.
J Clin Med ; 10(13)2021 Jun 29.
Article em En | MEDLINE | ID: mdl-34209541
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Guideline Idioma: En Revista: J Clin Med Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Estados Unidos
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Guideline Idioma: En Revista: J Clin Med Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Estados Unidos