FDA regulation of allogeneic islets as a biological product.

FDA regulation of allogeneic islets as a biological product. Research Abstract Details 

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FDA regulation of allogeneic islets as a biological product. Abstract Text:

Darin J Weber,

This article describes the Food and Drug Administration's recent manufacturing review experience with investigational new drug applications submitted for allogeneic pancreatic islets of Langerhans for the treatment of type 1 diabetes mellitus. In addition, considerations of islet preparation issues that will need to be resolved before the submission of a biologics license application are discussed.

FDA regulation of allogeneic islets as a biological product. Publishing Authors By Initials

DJ Weber,

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FDA regulation of allogeneic islets as a biological product. Journal Published:

PUBLICATION TYPE: Journal Article

Journal: Cell biochemistry and biophysics

VOLUME: 40

Page Numbers: 19-22

Journal Abbreviation: Cell Biochem. Biophys.

ISSN: 1085-9195

DAY: 3

MONTH: 08

YEAR: 2004

FDA regulation of allogeneic islets as a biological product. Information

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LANGUAGE: eng

NlmUniqueID: 9701934

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Grant and Affiliation Information for FDA regulation of allogeneic islets as a biological product.

AFFILIATION: US Food and Drug Administration, Center for Biologics Evaluation and Research, Offices of Cells, Tissue and Gene Therapies, Division of Cellular and Gene Therapies, Rockville, MD.

Country: United States

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MEDLINETA: Cell Biochem Biophys

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