Regarding minors, drug developers must deal with two layers of reality: the real world and the regulatory view. FDA and EMA approved drugs for “children” separately, defining “children” as <18 years as if they were another species. The EMA demands a "pediatric investigation plan" (PIP) years before marketing authorization application, the FDA an initial pediatric study plan (iPSP) 60 days after the end-of-phase-2 meeting;
Newborns are really vulnerable and immature, but they grow and mature fast. The regulatory administrative age limits confer an inadequate physiological connotation to the 18th birthday. The word “child” has different meanings: we associate with children small, vulnerable persons; but administratively, anybody <18 years is a "child".