Literature DB >> 34231527

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.

Piotr Witkowski1, Roi Anteby2,3, Oyedolamu K Olaitan4, Racheal C Forbes5, Silke Niederhaus6, Camilo Ricordi7, Jeffrey H Fair8, Robert C Harland9.   

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Year:  2021        PMID: 34231527     DOI: 10.1097/TP.0000000000003880

Source DB:  PubMed          Journal:  Transplantation        ISSN: 0041-1337            Impact factor:   4.939


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  1 in total

1.  Islets Transplantation at a Crossroads - Need for Urgent Regulatory Update in the United States: Perspective Presented During the Scientific Sessions 2021 at the American Diabetes Association Congress.

Authors:  Piotr Witkowski; Louis H Philipson; John B Buse; R Paul Robertson; Rodolfo Alejandro; Melena D Bellin; Fouad Kandeel; David Baidal; Jason L Gaglia; Andrew M Posselt; Roi Anteby; Piotr J Bachul; Yaser Al-Salmay; Kumar Jayant; Angelica Perez-Gutierrez; Rolf N Barth; John J Fung; Camillo Ricordi
Journal:  Front Endocrinol (Lausanne)       Date:  2022-01-06       Impact factor: 5.555

  1 in total

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