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Clinical holds for cell and gene therapy trials: Risks, impact, and lessons learned

The recent increase in cell and gene therapies being developed has been coupled with a disproportionate increase in Food and Drug Administration (FDA)-mandated clinical holds. Aiming to better understand causes and secondary effects of these clinical holds on biotechnology companies, we analyzed 33...

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Detalles Bibliográficos
Autores principales: Wills, Carolyn A., Drago, Daniela, Pietrusko, Robert G.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Society of Gene & Cell Therapy 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10597781/
https://www.ncbi.nlm.nih.gov/pubmed/37886603
http://dx.doi.org/10.1016/j.omtm.2023.101125

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