Closing the Gap in Pediatric Oncology Drug Development: The Regulatory Landscape and the RACE for Children Act

The current regulatory environment can help support sponsors with the complex efforts involved in pediatric oncology drug development, as regulatory agencies and legislative acts have helped encourage, incentivize or even require the conduct of pediatric trials in other indications. This white paper provides a brief history of how pediatric cancer treatments have progressed, outlines how regulatory changes have impacted the field of pediatric drug development and provides guidance on applying current regulations, such as the RACE for Children Act, which is focused on pediatric oncology. This change should serve to enhance an inclusive regulatory strategy for oncologic drug development.

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Rare Disease