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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 P, Odorico J, Pyda J, Anteby R, Stratta RJ, Schrope BA, Hardy MA, Buse J, Leventhal JR, Cui W, Hussein S, Niederhaus S, Gaglia J, Desai CS, Wijkstrom M, Kandeel F, Bachul PJ, Becker YT, Wang LJ, Robertson RP, Olaitan OK, Kozlowski T, Abrams PL, Josephson MA, Andreoni KA, Harland RC, Kandaswamy R, Posselt AM, Szot GL, Ricordi C, On Behalf Of The Islets For Us Collaborative. Witkowski P, et al. Among authors: olaitan ok. J Clin Med. 2021 Jun 29;10(13):2878. doi: 10.3390/jcm10132878. J Clin Med. 2021. PMID: 34209541 Free PMC article.
C-peptide levels do not correlate with pancreas allograft failure: Multicenter retrospective analysis and discussion of the new OPT definition of pancreas allograft failure.
Niederhaus SV, Carrico RJ, Prentice MA, Fox AC, Mujtaba MA, Dunn TB, Olaitan OK, Fisher JS, Stratta RJ, Farney AC, Odorico JS, Fridell JA. Niederhaus SV, et al. Among authors: olaitan ok. Am J Transplant. 2019 Apr;19(4):1178-1186. doi: 10.1111/ajt.15118. Epub 2018 Oct 22. Am J Transplant. 2019. PMID: 30230218 Free article.
The demise of islet allotransplantation in the United States: A call for an urgent regulatory update.
Witkowski P, Philipson LH, Kaufman DB, Ratner LE, Abouljoud MS, Bellin MD, Buse JB, Kandeel F, Stock PG, Mulligan DC, Markmann JF, Kozlowski T, Andreoni KA, Alejandro R, Baidal DA, Hardy MA, Wickrema A, Mirmira RG, Fung J, Becker YT, Josephson MA, Bachul PJ, Pyda JS, Charlton M, Millis JM, Gaglia JL, Stratta RJ, Fridell JA, Niederhaus SV, Forbes RC, Jayant K, Robertson RP, Odorico JS, Levy MF, Harland RC, Abrams PL, Olaitan OK, Kandaswamy R, Wellen JR, Japour AJ, Desai CS, Naziruddin B, Balamurugan AN, Barth RN, Ricordi C; “Islets for US” Collaborative. Witkowski P, et al. Among authors: olaitan ok. Am J Transplant. 2021 Apr;21(4):1365-1375. doi: 10.1111/ajt.16397. Epub 2021 Feb 10. Am J Transplant. 2021. PMID: 33251712 Free PMC article.
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.
Witkowski P, Anteby R, Olaitan OK, Forbes RC, Niederhaus S, Ricordi C, Fair JH, Harland RC; Islets for US Collaborative; Cell Transplantation Committee of the American Society of Transplant Surgeons (ASTS). Witkowski P, et al. Among authors: olaitan ok. Transplantation. 2021 Dec 1;105(12):e409-e410. doi: 10.1097/TP.0000000000003880. Transplantation. 2021. PMID: 34231527 No abstract available.
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