The NIH BPCA program is mandated to:
- Identify drugs in need of further study
- Prioritize needs in pediatric therapeutics
- Sponsor clinical studies of prioritized drugs
- Submit clinical study data to the U.S. Food and Drug Administration (FDA) for label change consideration
- Disseminate clinical study data to the public
To accomplish these activities, NICHD collaborates with the FDA, other NIH institutes, pediatric experts, and the public to help maximize its research.
Outcomes from the program include:
- Label changes that improve dosing guidelines for neonatal practitioners (acyclovir, ampicillin, caffeine)
- Label changes that lead to international updates in drug label information (acyclovir)
- A centralized resource (framework) of good practice guidelines and other resources that can be used for all stakeholders involved in pediatric drug development research
- An innovative infrastructure of experts in pediatric clinical trial design as well as a stable infrastructure of clinical sites involved in pediatric drug development research
- A unique wealth of methodologies for drug development assays for medications used in children
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