Physician experiences with and perceptions of risk evaluation and mitigation strategy programs with elements to assure safe use

PURPOSE: The US Food and Drug Administration (FDA) Amendments Act of 2007 authorized the FDA to require risk evaluation and mitigation strategy (REMS) programs for drugs with important safety concerns. REMS can have elements to assure safe use (ETASU), such as patient registries, dispensing restrict...

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Detalles Bibliográficos
Autores principales: Sarpatwari, Ameet, Brown, Beatrice L., McGraw, Sarah A., Dejene, Sara Z., Abdurrob, Abdurrahman, Kesselheim, Aaron S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2023
Materias:
Research Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10325060/
https://www.ncbi.nlm.nih.gov/pubmed/37410756
http://dx.doi.org/10.1371/journal.pone.0288008

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10325060/
https://www.ncbi.nlm.nih.gov/pubmed/37410756
http://dx.doi.org/10.1371/journal.pone.0288008

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