Labeling Changes and Costs for Clinical Trials Performed Under the US Food and Drug Administration Pediatric Exclusivity Extension, 2007 to 2012

IMPORTANCE: Pharmaceutical manufacturers can receive 6 additional months of market exclusivity for performing pediatric clinical trials of brand-name drugs widely used in adults. Congress created this incentive in 1997 because these drugs were being used off-label in children without such trials. OB...

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Detalles Bibliográficos
Publicado en:JAMA Intern Med
Autores principales: Sinha, Michael S., Najafzadeh, Mehdi, Rajasingh, Elizabeth K., Love, James, Kesselheim, Aaron S.
Formato: Artigo
Lenguaje:Inglês
Publicado: American Medical Association 2018
Materias:
Original Investigation
Acceso en línea:https://ncbi.nlm.nih.gov/pmc/articles/PMC6248195/
https://ncbi.nlm.nih.gov/pubmed/30264138
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1001/jamainternmed.2018.3933
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