There has historically been limited access to drugs in development for testing in children. New regulations from both the European Medicines Agency (EMEA) and the US Food and Drug Administration have been implemented to accelerate testing drug candidates in children. Representatives from the EMEA and the US FDA will discuss the new regulatory initiatives designed to increase the availability and testing of new drug candidates in pediatrics. Familiarity with these new regulations is the first step in incorporating the changes into clinical research planning.