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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...
| Autores principales: | , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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Nature Publishing Group UK
2022
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| Materias: | |
| 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 |