Regulatory Framework for Academic Investigator-Sponsored Investigational New Drug Development of Cell and Gene Therapies in the USA

PURPOSE OF REVIEW: The promise of cell and gene therapy (CGT) products for a multitude of diseases has revitalized investigators to advance novel CGT product candidates to first-in-human trials by pursuing the investigational new drug (IND) mechanism administered by the United States (US) Food and D...

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Detalles Bibliográficos
Autores principales: Dasgupta, Anindya, Herzegh, Kristen, Spencer, H. Trent, Doering, Christopher, Day, Eric, Swaney, William P.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2021
Materias:
Stem Cells: Policies from the Bench to the Clinic (G Moll and N Drzeniek, Section Editors)
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8483165/
https://www.ncbi.nlm.nih.gov/pubmed/34608428
http://dx.doi.org/10.1007/s40778-021-00196-4

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8483165/
https://www.ncbi.nlm.nih.gov/pubmed/34608428
http://dx.doi.org/10.1007/s40778-021-00196-4

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