Pediatric Clinical Studies: New Report From the NAS

WASHINGTON — Federal laws that motivate or require drug and biologic developers to conduct pediatric studies have yielded beneficial information to guide the use of medications in children, says a new report by the Institute of Medicine.  Still, studies involving children continue to be limited, especially in certain areas such as medications’ use in newborns and long-term safety and effectiveness in children.  The report identifies ways that Congress and the U.S. Food and Drug Administration could further improve the utility of clinical information obtained from pediatric studies, including expanding innovative strategies to research drugs and biologics in children, using FDA’s authority to require long-term pediatric studies of possible safety risks, and giving FDA flexibility to impose sanctions for unreasonably delayed studies.