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Pragmatic applications of implementation science frameworks to regulatory science: an assessment of FDA Risk Evaluation and Mitigation Strategies (REMS) (2014–2018)

BACKGROUND: A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program for certain medications with serious safety concerns required by the U.S. Food and Drug Administration (FDA) of manufacturers to implement to help ensure the benefits of the medication outweigh its risks. FDA is en...

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Detalles Bibliográficos
Autores principales: Huynh, Linda, Toyserkani, Gita A., Morrato, Elaine H.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8348874/
https://www.ncbi.nlm.nih.gov/pubmed/34362367
http://dx.doi.org/10.1186/s12913-021-06808-3