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The effect of adding real-world evidence to regulatory submissions on the breadth of population indicated for rare disease medicine treatment by the European Medicines Agency
BACKGROUND: Despite calls for the use of additional real-world evidence (RWE) during drug development, rates of inclusion at the regulatory stage remain low. The medicine adoption model suggests that providing additional RWE to regulators would result in a wider indicated population than providing r...
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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BioMed Central
2022
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9069778/ https://www.ncbi.nlm.nih.gov/pubmed/35509059 http://dx.doi.org/10.1186/s40545-022-00433-z |