IOM issues report on pediatric studies

The Institute of Medicine said in a report Wednesday that two laws intended to motivate and require companies to conduct pediatric studies have led to improvements in the availability of data in children. However, IOM said studies involving children remain limited, especially trials in newborns and those evaluating long-term drug safety and effectiveness. The report suggested FDA consider more frequent use of its authority to require long-term pediatric studies. It also said Congress could consider giving the agency more flexibility to impose sanctions for unreasonably delayed pediatric studies. IOM conducted the report at FDA's request. ...