The hospital exemption pathway for the approval of advanced therapy medicinal products: an underused opportunity? The case of the CAR-T ARI-0001

In February 2021, the ‘Advanced Therapy Medicinal Product’ (ATMP) ARI-0001 (CART19-BE-01), developed at Hospital Clínic de Barcelona (Spain), received authorization from the Spanish Agency of Medicines and Medical Devices (AEMPS) under the ‘hospital exemption’ (HE) approval pathway for the treatment...

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Detalles Bibliográficos
Autores principales: Trias, Esteve, Juan, Manel, Urbano-Ispizua, Alvaro, Calvo, Gonzalo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group UK 2022
Materias:
Perspective
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8821008/
https://www.ncbi.nlm.nih.gov/pubmed/35046545
http://dx.doi.org/10.1038/s41409-021-01463-y

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8821008/
https://www.ncbi.nlm.nih.gov/pubmed/35046545
http://dx.doi.org/10.1038/s41409-021-01463-y

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