Use of real-world evidence in postmarketing medicines regulation in the European Union: a systematic assessment of European Medicines Agency referrals 2013–2017

OBJECTIVES: To assess the use, and evaluate the usefulness, of non-interventional studies and routinely collected healthcare data in postmarketing assessments conducted by the European Medicines Agency (EMA). DESIGN: We reviewed and systematically assessed all referrals to the EMA made due to safety...

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Detalles Bibliográficos
Autores principales: Brown, Jeremy Philip, Wing, Kevin, Evans, Stephen J, Bhaskaran, Krishnan, Smeeth, Liam, Douglas, Ian J
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2019
Materias:
Pharmacology and Therapeutics
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6830614/
https://www.ncbi.nlm.nih.gov/pubmed/31662354
http://dx.doi.org/10.1136/bmjopen-2018-028133

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6830614/
https://www.ncbi.nlm.nih.gov/pubmed/31662354
http://dx.doi.org/10.1136/bmjopen-2018-028133

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