Regulatory approval of pharmaceuticals without a randomised controlled study: analysis of EMA and FDA approvals 1999–2014

INTRODUCTION: The efficacy of pharmaceuticals is most often demonstrated by randomised controlled trials (RCTs); however, in some cases, regulatory applications lack RCT evidence. OBJECTIVE: To investigate the number and type of these approvals over the past 15 years by the European Medicines Agency...

Descripción completa

Detalles Bibliográficos
Autores principales: Hatswell, Anthony J, Baio, Gianluca, Berlin, Jesse A, Irs, Alar, Freemantle, Nick
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2016
Materias:
Pharmacology and Therapeutics
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4932294/
https://www.ncbi.nlm.nih.gov/pubmed/27363818
http://dx.doi.org/10.1136/bmjopen-2016-011666

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4932294/
https://www.ncbi.nlm.nih.gov/pubmed/27363818
http://dx.doi.org/10.1136/bmjopen-2016-011666

Ejemplares similares