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Towards a better use of scientific advice for developers of advanced therapies
Scientific advice (SA) is an important tool offered by regulators to help developers generate robust evidence on a medicine's benefits and risks. Drawing on accumulated experience and looking at the SA provided by the European Medicines Agency in 2018 to advanced therapy medicinal products orig...
Autores principales: | Tavridou, Anna, Rogers, Dolca, Bonelli, Milton, Schiel, Anja, Hidalgo‐Simon, Ana |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8247399/ https://www.ncbi.nlm.nih.gov/pubmed/33237580 http://dx.doi.org/10.1111/bcp.14672 |
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