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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...

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Detalles Bibliográficos
Autores principales: Tavridou, Anna, Rogers, Dolca, Bonelli, Milton, Schiel, Anja, Hidalgo‐Simon, Ana
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2020
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