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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 statesBasel stadtUnited kingdomCity ofGianvincenzo zuccottiMassimo molteniHarry shirkeyEarlb ettienneJ clin pharmacologJ clin pharmacolKlaus roseEmilio clementiJapanese society for pediatric clinical pharmacologyCollege of pharmacyEuropean parliamentEuropean society for developmental