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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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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BioMed Central
2016
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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 |