The Interdisciplinary Stem Cell Institute’s Use of Food and Drug Administration-Expanded Access Guidelines to Provide Experimental Cell Therapy to Patients With Rare Serious Diseases

The U.S. Food and Drug Administration (FDA) provides guidance for expanded access to experimental therapies, which in turn plays an important role in the Twenty-first Century Cures Act mandate to advance cell-based therapy. In cases of incurable diseases where there is a lack of alternative treatmen...

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Detalles Bibliográficos
Autores principales: Khan, Aisha, Bellio, Michael A., Schulman, Ivonne H., Levi, Allan D., Longsomboon, Bangon, Brooks, Adriana, Valasaki, Krystalenia, DiFede, Darcy L., Pujol, Marietsy V., Yavagal, Dileep R., Bates, Karen E., Si, Ming-Sing, Kaushal, Sunjay, Green, Barth A., Anderson, Kimberly D., Guest, James D., Burks, Stephen Shelby, Silvera, Risset, Santamaria, Andrea J., Lalwani, Anil, Dietrich, W. Dalton, Hare, Joshua M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2021
Materias:
Cell and Developmental Biology
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8217825/
https://www.ncbi.nlm.nih.gov/pubmed/34169074
http://dx.doi.org/10.3389/fcell.2021.675738

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