Many drugs used in children today are used off-label, without adequate understanding of appropriate dose, safety, or efficacy. Over the years, results from the BPCA research program and clinical studies have led to several changes in medication labels—improving how medicines and medical devices are prescribed and used in newborns, infants, and children.
BPCA offers the following study summaries for researchers, healthcare providers, and parents who are interested in learning more about specific study results. Drugs with improved pediatric labeling as a result of the BPCA program are marked with an asterisk. Some of the studies have been submitted to the U.S. Food and Drug Administration (FDA) for label change consideration and are marked as such within the document. Other studies have not yet been submitted to the FDA.