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The European Medicines Agency: A Modern Robin Hood?

Many studies with a stated goal of advancing child health care in administratively-defined minors have no clinical value and may even harm young patients. ....

United Kingdom , New York , United States , Basel Stadt , City Of , Earlb Ettienne , Robin Hood , Klaus Rose , Ethics International , Howard University , European Medicines Agency , Lancet Planetary Health , Lancet Planet Health , Drug Administration Amendments , Pediatric Drug Development , Drug Companies , European Union , European Parliament , J Public Health , Front Public Health , Public Health Crisis In America , Brasseurd Development , College Of Pharmacy , Stone Age , Assistant Dean , Graduate Programs ,

Have Children Truly Ever Been 'Therapeutic Orphans?'

Imposing the FDA on-label/off-label framework on administratively defined "children" resulted in a regulatory demand for pediatric studies that had no basis in clinical medicine, with the exception of the small group of preterm newborns. ....

United States , Basel Stadt , United Kingdom , City Of , Gianvincenzo Zuccotti , Massimo Molteni , Harry Shirkey , Earlb Ettienne , J Clin Pharmacolog , J Clin Pharmacol , Klaus Rose , Emilio Clementi , Japanese Society For Pediatric Clinical Pharmacology , College Of Pharmacy , European Parliament , European Society For Developmental , Unlicensed Use On Health Care Laws , Mathis Ll Eds Pediatric Drug Development , Network Historical , European Medicines Agency , Us Department Of Health , Drug Law Institute , Human Services , European Society For Perinatal , Revolution In Pediatric Drug Development , Ethics International ,