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The potential investment impact of improved access to accelerated approval on the development of treatments for low prevalence rare diseases
BACKGROUND: Over 95% of rare diseases lack treatments despite many successful treatment studies in animal models. To improve access to treatments, the Accelerated Approval (AA) regulations were implemented allowing the use of surrogate endpoints to achieve drug approval and accelerate development of...
| Autores principales: | , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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BioMed Central
2011
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3149566/ https://www.ncbi.nlm.nih.gov/pubmed/21733145 http://dx.doi.org/10.1186/1750-1172-6-49 |