Evidence supporting regulatory-decision making on orphan medicinal products authorisation in Europe: methodological uncertainties

BACKGROUND: To assess uncertainty in regulatory decision-making for orphan medicinal products (OMP), a summary of the current basis for approval is required; a systematic grouping of medical conditions may be useful in summarizing information and issuing recommendations for practice. METHODS: A grou...

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Detalles Bibliográficos
Autores principales: Pontes, Caridad, Fontanet, Juan Manuel, Vives, Roser, Sancho, Aranzazu, Gómez-Valent, Mònica, Ríos, José, Morros, Rosa, Martinalbo, Jorge, Posch, Martin, Koch, Armin, Roes, Kit, Rengerink, Katrien Oude, Torrent-Farnell, Josep, Torres, Ferran
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2018
Materias:
Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6238348/
https://www.ncbi.nlm.nih.gov/pubmed/30442155
http://dx.doi.org/10.1186/s13023-018-0926-z

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6238348/
https://www.ncbi.nlm.nih.gov/pubmed/30442155
http://dx.doi.org/10.1186/s13023-018-0926-z

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