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Orphan devices: yesterday is history; tomorrow is mystery: towards a European orphan device directive?

BACKGROUND: Regulatory and economic frameworks stimulated the research and development of orphan drugs, but very little has been done for devices necessary for the in-vivo diagnosis, prevention and treatment of life-threatening conditions with a low prevalence/incidence. DISCUSSION: A general public...

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Detalles Bibliográficos
Autor principal: Dooms, Marc M
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4778287/
https://www.ncbi.nlm.nih.gov/pubmed/26939863
http://dx.doi.org/10.1186/s13023-016-0393-3