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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: on behalf of the islets for us collaborative. J Clin Med. 2021 Jun 29;10(13):2878. doi: 10.3390/jcm10132878. J Clin Med. 2021. PMID: 34209541 Free PMC article.