Completion Rate and Reporting of Mandatory Pediatric Postmarketing Studies Under the US Pediatric Research Equity Act

IMPORTANCE: Many medicines prescribed to children have not been studied or formally approved for pediatric use. The Pediatric Research Equity Act of 2003 authorized the US Food and Drug Administration (FDA) to require pediatric clinical studies. OBJECTIVE: To evaluate the characteristics, completion...

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Bibliografische gegevens
Gepubliceerd in:JAMA Pediatr
Hoofdauteurs: Hwang, Thomas J., Orenstein, Liat, Kesselheim, Aaron S., Bourgeois, Florence T.
Formaat: Artigo
Taal:Inglês
Gepubliceerd in: American Medical Association 2018
Onderwerpen:
Original Investigation
Online toegang:https://ncbi.nlm.nih.gov/pmc/articles/PMC6583440/
https://ncbi.nlm.nih.gov/pubmed/30452498
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1001/jamapediatrics.2018.3416
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