Understanding New FDA Guidance For Pediatric Oncology Studies
A Sponsor’s Guide to the FDA Research to Accelerate Cures and Equity (RACE) for Children Act
The Research to Accelerate Cures and Equity (RACE) for Children Act aims to improve and expand treatment options for pediatric cancer patients by mandating that all new adult oncology drugs also be tested in children when the molecular targets are relevant to a particular childhood cancer.
Enacted August 18, 2017, as part of the Food and Drug Administration (FDA) Reauthorization Act (FDARA), it amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise and extend the user-fee programs for drugs, medical devices, generic drugs, and biosimilar biological products and for other purposes.