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Did FDA Decisionmaking Affect Anti-Psychotic Drug Prescribing in Children?: A Time-Trend Analysis

BACKGROUND: Following Food and Drug Administration (FDA) approval, many drugs are prescribed for non-FDA-approved (“off-label”) uses. If substantial evidence supports the efficacy and safety of off-label indications, manufacturers can pursue formal FDA approval through supplemental new drug applicat...

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Detalles Bibliográficos
Autores principales: Wang, Bo, Franklin, Jessica M., Eddings, Wesley, Landon, Joan, Kesselheim, Aaron S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4816295/
https://www.ncbi.nlm.nih.gov/pubmed/27032095
http://dx.doi.org/10.1371/journal.pone.0152195