Pancreatic islets quality and potency cannot be verified as required for drugs: Reflection on the FDA review of a biological license application for human islets

Islets for US Collaborative; Cell Transplantation Committee of the American Society of Transplant Surgeons (ASTS)

doi:10.1097/TP.0000000000003880

Pancreatic islets quality and potency cannot be verified as required for drugs: Reflection on the FDA review of a biological license application for human islets

Islets for US Collaborative
, Cell Transplantation Committee of the American Society of Transplant Surgeons (ASTS)

Research output: Contribution to journal › Letter › peer-review

Original language	English (US)
Pages (from-to)	E409-E410
Journal	Transplantation
Volume	105
Issue number	12
DOIs	https://doi.org/10.1097/TP.0000000000003880
State	Published - Dec 1 2021
Externally published	Yes

ASJC Scopus subject areas

Transplantation

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10.1097/TP.0000000000003880

Cite this

Pancreatic islets quality and potency cannot be verified as required for drugs: Reflection on the FDA review of a biological license application for human islets. / Islets for US Collaborative; Cell Transplantation Committee of the American Society of Transplant Surgeons (ASTS).
In: Transplantation, Vol. 105, No. 12, 01.12.2021, p. E409-E410.

Research output: Contribution to journal › Letter › peer-review

Islets for US Collaborative & Cell Transplantation Committee of the American Society of Transplant Surgeons (ASTS) 2021, 'Pancreatic islets quality and potency cannot be verified as required for drugs: Reflection on the FDA review of a biological license application for human islets', Transplantation, vol. 105, no. 12, pp. E409-E410. https://doi.org/10.1097/TP.0000000000003880

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title = "Pancreatic islets quality and potency cannot be verified as required for drugs: Reflection on the FDA review of a biological license application for human islets",

author = "\{Islets for US Collaborative\} and \{Cell Transplantation Committee of the American Society of Transplant Surgeons (ASTS)\} and Piotr Witkowski and Roi Anteby and Olaitan, \{Oyedolamu K.\} and Forbes, \{Racheal C.\} and Silke Niederhaus and Camilo Ricordi and Fair, \{Jeffrey H.\} and Harland, \{Robert C.\}",

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AU - Islets for US Collaborative

AU - Cell Transplantation Committee of the American Society of Transplant Surgeons (ASTS)

AU - Witkowski, Piotr

AU - Anteby, Roi

AU - Olaitan, Oyedolamu K.

AU - Forbes, Racheal C.

AU - Niederhaus, Silke

AU - Ricordi, Camilo

AU - Fair, Jeffrey H.

AU - Harland, Robert C.

PY - 2021/12/1

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M3 - Letter

C2 - 34231527

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SN - 0041-1337

VL - 105

SP - E409-E410

JO - Transplantation

JF - Transplantation

IS - 12

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Pancreatic islets quality and potency cannot be verified as required for drugs: Reflection on the FDA review of a biological license application for human islets

ASJC Scopus subject areas

Access to Document

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