BPCA is a congressionally mandated activity intended to enhance pediatric therapeutics, including, but not limited to, activities involving drugs, biologics, vaccines, devices, pediatric formulations and other therapeutic modifications. The intent of the legislation is to develop approaches, including preclinical and clinical methodologies that will provide optimal approaches for treating diseases in childhood. The NICHD, Obstetric and Pediatric Pharmacology Branch plans, implements an manages all NIH activities in support of BPCA and seeks to establish this new requirement by issuances of this IAA to the FDA.
