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Pediatric Medication Studies: A New Challenge for Institutional Review Boards, Ethics Committees

Institutional review boards and ethics committees have seen it as their main task in the past few decades to protect children from questionable studies; however, they are faced with a new challenge with pediatric drug development. ....

New York , United States , Basel Stadt , Hastings Center , City Of , United Kingdom , Eteläuomen Läi , J Clin Pharmacol , J Womens Dermatol , Chemother Pharmacol , Klaus Rose , Josef Mengele , Earlb Ettienne , College Of Pharmacy , World Medical Association , European Medicines Agency , European Society For Developmental , Development Of Paediatric Medicines In Europe , Oxford University , Us Public Health Service , Behavioral Research , Ethics International , National Research , Oxford University Press , American Academy Of Pediatrics , Ethical Principles For Medical Research Involving Human ,

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 ,