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Pediatric Drug Trials: Safety and Transparency

OBJECTIVE: To quantify the frequency and type of new safety information arising from studies performed under the auspices of the Pediatric Exclusivity Program, to describe the dissemination of these findings in the peer-reviewed literature and compare this with the FDA review, and to describe their...

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Bibliografiske detaljer
Main Authors: Benjamin, Daniel K., Smith, P. Brian, Sun, Jessica M., Murphy, M. Dianne, Avant, Debbie, Mathis, Lisa, Rodriguez, William, Califf, Robert M., Li, Jennifer S.
Format: Artigo
Sprog:Inglês
Udgivet: 2009
Fag:
Online adgang:https://ncbi.nlm.nih.gov/pmc/articles/PMC2792563/
https://ncbi.nlm.nih.gov/pubmed/19996043
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1001/archpediatrics.2009.229
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