Risk Evaluation and Mitigation Strategies (REMSs): Are They Improving Drug Safety? A Critical Review of REMSs Requiring Elements to Assure Safe Use (ETASU)

Risk Evaluation and Mitigation Strategies (REMSs) with Elements to Assure Safe Use (ETASU) are requested for drugs with significant safety risks. We reviewed REMS programs issued since 2011 to evaluate their rationales, characteristics, and consistencies, and evaluated their impact on improving drug...

Descripción completa

Detalles Bibliográficos
Autor principal: Boudes, Pol F.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2017
Materias:
Review Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5427046/
https://www.ncbi.nlm.nih.gov/pubmed/28160230
http://dx.doi.org/10.1007/s40268-017-0175-y

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5427046/
https://www.ncbi.nlm.nih.gov/pubmed/28160230
http://dx.doi.org/10.1007/s40268-017-0175-y

Ejemplares similares