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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Detalles Bibliográficos
Autor principal: Jandhyala, Ravi
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Research
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

Internet

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

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