White Paper

Understanding New FDA Guidance For Pediatric Oncology Studies: A Sponsor's Guide To The FDA RACE For Children Act

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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.

RACE requires that any original new drug application or biologics license application submitted on or after August 18, 2020, for a new active ingredient must contain reports of molecularly targeted pediatric cancer investigations (unless a deferral or waiver of that requirement is granted) if the drug is:

  • Intended for the treatment of an adult cancer, and
  • Directed at a molecular target that the FDA determines to be substantially relevant to the growth or progression of a pediatric cancer.

This requirement for pediatric investigation applies even if the adult cancer indication does not occur in the pediatric population and the drug is for an adult indication for which orphan designation has been granted. In December 2019, the FDA issued a Draft Guidance that is the subject of this white paper. In January 2020, the agency also issued a Questions and Answers Draft Guidance related to FDARA implementation.

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