Regulatory Landscape of Pediatric Oncology Drug Development in the US: Implications for Sponsors of the RACE Act
A review on the progression of regulations pertaining to pediatric drug development in oncology and what sponsors should know as they devise their oncology drug development plan.
In the US, cancer is the leading cause of death from disease in children. For the past 25 years, the US Food and Drug Administration (FDA) has worked to accelerate the development of promising drugs for pediatric cancer patients, achieving limited success. In that time, the legislative strategy has moved from voluntary guidelines for sponsors to mandatory directives.
The most recent legislation, the Research to Accelerate Cures and Equity (RACE) for Children Act, which was passed into law August 18, 2017 as Title V of the FDA Reauthorization Act (FDARA), is more pointedly aimed at furthering the development of pediatric oncology treatments.
It requires all marketing applications for new adult oncology drugs submitted after August 18, 2020 to include evaluations of their safety and efficacy in pediatric cancers if they share a molecular target that could be relevant to treating children.
This means that pediatric oncology drug development should generally be coordinated with oncology development for adults as part of an overall drug development plan, as articulated by a FDA Advisory Committee on the RACE Act in its Consensus Statement.
Download the white paper below for a review on the progression of regulations pertaining to pediatric drug development in oncology and learn what sponsors should know as they devise their oncology drug development plan.
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