Adaptation for Regulatory Application: A Content Analysis of FDA Risk Evaluation and Mitigation Strategies Assessment Plans (2014–2018) Using RE-AIM

Background: Risk Evaluation and Mitigation Strategies (REMS) are safety programs that U.S. Food and Drug Administration can require to ensure a drug's benefits outweigh its risks and can be considered public health interventions. FDA's 2019 draft Guidance for Industry on REMS Assessments e...

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Detalles Bibliográficos
Autores principales: Toyserkani, Gita A., Huynh, Linda, Morrato, Elaine H.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2020
Materias:
Public Health
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7052173/
https://www.ncbi.nlm.nih.gov/pubmed/32158741
http://dx.doi.org/10.3389/fpubh.2020.00043

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7052173/
https://www.ncbi.nlm.nih.gov/pubmed/32158741
http://dx.doi.org/10.3389/fpubh.2020.00043

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