How does FDA define “children”?
For drugs, a child is defined as a person up to 17 years of age. For devices, 21 years of age is the upper limit. back to top Q: Are medications that are intended for children clinically tested on children? A: If the product is to be used only for children, then it must be studied in the pediatric population. However, many therapies are developed for adults and then used in children without having been studied in children. Therefore, most marketed products that are mostly used in adults have not been studied in children—even though they may be used by doctors to treat children. There has been improvement in this area in regard to prescription drugs. As of 2008, an estimated 50 to 60 percent of prescription drugs used to treat children have been studied in some part of the pediatric population. Still, the likelihood that a medicine has actually been studied in neonates—children less than a month old—is close to zero. So nearly a decade into the 21st Century, most medicines intended for
