Infections caused by multi-drug resistant (MDR) bacteria have emerged as an important cause of morbidity and mortality. It is clear that children, especially newborns, need access to the innovative therapies being developed to address the challenge of treating patients with MDR bacterial infections. As this access is driven by regulatory approval and labeling for use in children, it is critical for the work supporting this process be completed as efficiently as possible. An analysis of approval and labeling of new antibiotics since 2000 indicates that it has taken up to 7.4 years for sponsors to satisfy the requirements for FDA approval and labeling of new antibiotics for use in children after approval and labeling occurred in adults (Mc Neeley, 2022). In this analysis no trend was evident indicating that the period between adult and pediatric approvals is shortening.

The Institute for Advancing Clinical Trials for Children has convened a group of experts to develop a webinar series aimed at identifying the challenges in completing the work required for regulatory approval and recommend action items that will address these challenges.