Strategy for communicating benefit-risk decisions: a comparison of regulatory agencies' publicly available documents

The assessment report formats of four major regulatory reference agencies, US Food and Drug Administration, European Medicines Agency, Health Canada, and Australia's Therapeutic Goods Administration were compared to a benefit-risk (BR) documentation template developed by the Centre for Innovati...

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Detalles Bibliográficos
Autores principales: Leong Wai Yeen, James, Salek, Sam, Walker, Stuart
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2014
Materias:
Pharmacology
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4255503/
https://www.ncbi.nlm.nih.gov/pubmed/25538620
http://dx.doi.org/10.3389/fphar.2014.00269

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4255503/
https://www.ncbi.nlm.nih.gov/pubmed/25538620
http://dx.doi.org/10.3389/fphar.2014.00269

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