With the passage of the Food and Drug Administration Safety and Innovation Act (FDASIA) and the permanent reauthorization of the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA), the promise of earlier and meaningful interactions with FDA regarding pediatric drug development is now a reality. This, coupled with the EU Pediatric Legislation that provides for a required and predictable process for pediatric discussions with EMA, sets the stage for global pediatric development programs that can align with needs of children and address concerns of the FDA and EMA.

In this session we will explore initiatives that each FDA and EMA oversee to advance pediatric research. We will also explore those initiatives the Health Authorities are undertaking together to better advance unmet and underserved needs of children. Updates on monthly cluster calls, joint FDA/EMA pediatric program review, the EMA five year report, and use of MedDRAź to help identify additional pediatric studies needed will be just some of the topics to be discussed.