If a drug that is already on the market has the potential to help adults and children who have the same disease, or if it is widely used in children and the absence of labeling seems dangerous, the FDA can require that the drug undergo pediatric study.
If a drug that is already on the market has the potential to help adults and children who have the same disease, or if it is widely used in children and the absence of labeling seems dangerous, the FDA can require that the drug undergo pediatric study.