Industry Perspective of Pediatric Drug Development in the United States: Involvement of the European Union Countries

[1] Bellis JR(2014)Adverse drug reactions and off-label and unlicensed medicines in children: a prospective cohort study of unplanned admissions to a paediatric hospital Br J Clin Pharmacol 77 545-553

[2] Kirkham JJ(2012)Off-label drug use in pediatric patients Clin Pharmacol Ther 91 796-801

[3] Nunn AJ(2003)Pediatric drug labeling: improving the safety and efficacy of pediatric therapies JAMA 290 905-911

[4] Pirmohamed M(2016)Improvement of pediatric drug development: regulatory and practical frameworks Clin Ther 38 574-581

[5] Kimland E(2016)A Comparative review of waivers granted in pediatric drug development by FDA and EMA from 2007–2013 Therapeutic Innovation & Regulatory Science 50 639-647

[6] Odlind V(2013)Federal legislation and the advancement of neonatal drug studies J Pediatr 162 12-15

[7] Roberts R(2013)Analysis of pediatric clinical drug trials for neuropsychiatric conditions Pediatrics 131 1125-1131

[8] Rodriguez W(2014)Association between pediatric clinical trials and global burden of disease Pediatrics 133 78-87

[9] Murphy D(2014)A comparison of interventional clinical trials in rare versus non-rare diseases: an analysis of ClinicalTrials.gov Orphanet J Rare Dis 9 170-458

[10] Crescenzi T(2013)Investigation of the freely available easy-to-use software “EZR” for medical statistics Bone Marrow Transplant 48 452-71

[1] Bellis JR(2014)Adverse drug reactions and off-label and unlicensed medicines in children: a prospective cohort study of unplanned admissions to a paediatric hospital Br J Clin Pharmacol 77 545-553

[2] Kirkham JJ(2012)Off-label drug use in pediatric patients Clin Pharmacol Ther 91 796-801

[3] Nunn AJ(2003)Pediatric drug labeling: improving the safety and efficacy of pediatric therapies JAMA 290 905-911

[4] Pirmohamed M(2016)Improvement of pediatric drug development: regulatory and practical frameworks Clin Ther 38 574-581

[5] Kimland E(2016)A Comparative review of waivers granted in pediatric drug development by FDA and EMA from 2007–2013 Therapeutic Innovation & Regulatory Science 50 639-647

[6] Odlind V(2013)Federal legislation and the advancement of neonatal drug studies J Pediatr 162 12-15

[7] Roberts R(2013)Analysis of pediatric clinical drug trials for neuropsychiatric conditions Pediatrics 131 1125-1131

[8] Rodriguez W(2014)Association between pediatric clinical trials and global burden of disease Pediatrics 133 78-87

[9] Murphy D(2014)A comparison of interventional clinical trials in rare versus non-rare diseases: an analysis of ClinicalTrials.gov Orphanet J Rare Dis 9 170-458

[10] Crescenzi T(2013)Investigation of the freely available easy-to-use software “EZR” for medical statistics Bone Marrow Transplant 48 452-71