The development of rational therapeutics for infants and children has recently received much attention from the academic community, industry, the U.S. Congress, and the federal government.

The members of the Roundtable on Research and Development of Drugs, Biologics, and Medical Devices recognized that a variety of interesting and challenging issues are being raised, from several different perspectives, among a diverse group of interested and affected parties. Consequently, they requested that a workshop be held to explore such issues in depth. This report summarizes the proceedings of that workshop.