Recent recognition and industry acceptance of the unique therapeutic needs of pediatric patients has led to regulatory activity and development programs that are re-defining this market segment. The result has been a push by developers and formulators emphasizing pediatric drug delivery - the creation of formulations engineered and packaged specifically for children to meet the needs of pediatric patient populations. Several factors are driving the growth of the pediatric drug delivery as a business strategy. The pediatric sector is forecast to be one of the fastest growing drug markets over the next ten years. By circumventing the normal clinical trial and regulatory approval process, off-label prescribing and extemporaneous formulations add risk to pediatric prescribing. The growing availability of drugs targeted for childhood illnesses is focusing efforts on child-friendly delivery methods. To encourage drug developers to perform clinical testing in pediatric age groups for drugs anticipated to be used for children, the FDA has published special rules and guidance that include incentives. The European Commission adopted similar regulations in 2005. These factors are converging to drive developments in pediatric drug delivery. 

Publication Date: March 2006