Licensing of Orphan Medicinal Products—Use of Real-World Data and Other External Data on Efficacy Aspects in Marketing Authorization Applications Concluded at the European Medicines Agency Between 2019 and 2021

Background: Reference to so-called real-world data is more often made in marketing authorization applications for medicines intended to diagnose, prevent or treat rare diseases compared to more common diseases. We provide granularity on the type and aim of any external data on efficacy aspects from...

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Detalles Bibliográficos
Autores principales: Naumann-Winter, Frauke, Wolter, Franziska, Hermes, Ulrike, Malikova, Eva, Lilienthal, Nils, Meier, Tania, Kalland, Maria Elisabeth, Magrelli, Armando
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Pharmacology
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9413272/
https://www.ncbi.nlm.nih.gov/pubmed/36034814
http://dx.doi.org/10.3389/fphar.2022.920336

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9413272/
https://www.ncbi.nlm.nih.gov/pubmed/36034814
http://dx.doi.org/10.3389/fphar.2022.920336

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