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    Economic return of clinical trials performed under the pediatric exclusivity program. 

    Benjamin, Daniel Kelly; Califf, Robert M; Eisenstein, EL; Goldsmith, JV; Grabowski, Henry G; Li, JS; Mangum, B; ... (10 authors) (JAMA, 2007-02-07)
    CONTEXT: In 1997, Congress authorized the US Food and Drug Administration (FDA) to grant 6-month extensions of marketing rights through the Pediatric Exclusivity Program if industry sponsors complete FDA-requested pediatric ...
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    Spending on postapproval drug safety. 

    Grabowski, Henry G; Kramer, JM; Ridley, David Blaine; Schulman, Kevin Alan; Tilson, HH (Health Aff (Millwood), 2006-03)
    Withdrawals of high-profile pharmaceuticals have focused attention on post-approval safety surveillance. There have been no systematic assessments of spending on postapproval safety. We surveyed drug manufacturers regarding ...
     

     

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    AuthorGrabowski, Henry G (2)
    Schulman, Kevin Alan (2)
    Benjamin, Daniel Kelly (1)Califf, Robert M (1)Eisenstein, EL (1)Goldsmith, JV (1)Kramer, JM (1)Li, JS (1)Mangum, B (1)Murphy, MD (1)... View MoreDate Issued2006 (1)2007 (1)TypeJournal article (2)SubjectCosts and Cost Analysis (2)Drug Approval (2)
    Drug Industry (2)
    United States (2)Clinical Trials as Topic (1)Cohort Studies (1)Drug Costs (1)Humans (1)Marketing (1)Pediatrics (1)... View MoreAffiliation of Duke Author(s)
    Clinical Science Departments (2)
    Duke (2)
    Duke Cancer Institute (2)Duke Clinical Research Institute (2)Duke Science & Society (2)Economics (2)Global Health Institute (2)Initiatives (2)Institutes and Centers (2)Institutes and Provost's Academic Units (2)... View More