This NCCAM Inter-Agency Agreement with NICHD in 2008 was in response to the re-authorization of the ?Best Pharmaceuticals for Children Act'(BPCA) under Public Law 107-109 [Jan 4, 2002]. The Best Pharmaceuticals for Children Act (BPCA) Program is a major activity for the Obstetric and Pediatric Pharmacology Branch (OPPB), a component of the Center for Research for Mothers and Children at the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). OPPB is responsible for developing and supporting a comprehensive national research and training effort to increase the knowledge base for understanding how to appropriately treat disease during pregnancy, infancy, and childhood using pharmaceuticals that are appropriately tested within their target populations. NICHD activities related to BPCA are intended to improve pediatric drug therapeutics through preclinical and clinical testing that lead to drug labeling change. This Inter-Agency Agreement in response to the Best Pharmaceuticals for Children Act establishes a process for studying on-patent and off-patent drugs for use in pediatric populations, and to improve pediatric therapeutics through collaboration on scientific investigation, clinical study design, weight of evidence, and ethical and labeling issues.