4381 Examination of FDA Pediatric Regulations: Inclusion of Pediatric Populations in Clinical Trials, 2016 - 2018

OBJECTIVES/GOALS: To assess whether FDA regulations aimed at the pediatric population following the Best Pharmaceuticals for Children Act (BPCA) of 2002 are effective, this study examines the inclusion of the pediatric population in recent clinical trials for drugs used by both adult and pediatric g...

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Detalles Bibliográficos
Autores principales: Ly, Annie, Uniyal, Apurva, Church, Terry
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Cambridge University Press 2020
Materias:
Translational Science, Policy, & Health Outcomes Science
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8823600/
http://dx.doi.org/10.1017/cts.2020.389

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8823600/
http://dx.doi.org/10.1017/cts.2020.389

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