On August 18, 2017, The RACE for Children Act was signed into law as Title V of the FDA Reauthorization Act (FDARA) to amend the Pediatric Research Equity Act (PREA) (21 U.S. Code 355c).
On August 17, 2021 the RACE for Children Act came into full effect.
The RACE for Children Act requires companies developing targeted cancer drugs for adults to develop pediatric study plans for those drugs in children with cancer when the molecular targets of the cancer drugs are substantially relevant to children’s cancers. In addition, the RACE for Children Act ends an exemption from PREA requirements for cancer drugs that have orphan status.
Pursuant to the RACE Act, the FDA published a list of relevant molecular targets for oncology that are viewed as substantially relevant to the growth and progression of a pediatric cancer, and that may now require pediatric study plans.