Pediatric Rule (U.S., 1998)

Drug development for children can be challenging for pharmaceutical manufacturers. Because of the rapidly changing physiological development from newborn to adolescent, changes in the body’s response to drugs, drug metabolism, and toxicity can also change over time with the growth of the child. Children are considered a vulnerable and protected population. Informed consent for participation in clinical drug trials cannot be legally obtained from the minor patient. In the case of older children who are able to understand the clinical trial risks and benefits to themselves and future patients, assent of the patient with parental permission is proposed for ethical research. These physiological and ethical challenges represent substantial hurdles in research and development of medications for pediatric use. Before the U.S. Food and Drug Administration ...