{"entity":{"id":"race-for-children-act","kind":"term","name":"RACE for Children Act","aka":["Research to Accelerate Cures and Equity for Children Act","FDARA Title V section 504","PREA molecular target amendment"],"tldr":"A US law that makes drug companies test new targeted cancer drugs in children whenever the drug's target matters in a childhood cancer, instead of letting them skip children because their cancers are rare.","summary":"The RACE for Children Act was enacted as Title V of the FDA Reauthorization Act (FDARA) of 2017 and took effect for applications submitted from 18 August 2020. It amended the Pediatric Research Equity Act (PREA) so that a new drug or biologic for an adult cancer must include a paediatric investigation if it is directed at a molecular target that the FDA judges 'substantially relevant to the growth or progression of a pediatric cancer', and it removed the orphan-drug exemption from PREA for such products. The FDA Oncology Center of Excellence maintains the relevant and non-relevant molecular target lists (updated after Pediatric Oncology Subcommittee of ODAC meetings) and issues written requests and waivers. The Act complements the EU Paediatric Regulation (EC 1901/2006), whose paediatric investigation plans (PIPs) had allowed class waivers for adult-only conditions; the EU is revising that regulation to adopt a mechanism-of-action test. In practice the two levers, together with the ACCELERATE Paediatric Strategy Forums, are why paediatric plans now accompany most new ALK, MEK, BRAF, NTRK, RET, BCL2, CDK4/6 and ADC programmes, and why tovorafenib, dabrafenib-trametinib and selpercatinib reached children within a few years of adult data.","asOf":"2026-09-10","links":[{"label":"FDA: relevant paediatric molecular target list","url":"https://www.fda.gov/about-fda/oncology-center-excellence/pediatric-oncology"},{"label":"FDARA 2017 (Public Law 115-52)","url":"https://www.congress.gov/bill/115th-congress/house-bill/2430"}],"tags":["nci-coverage","paediatric","regulatory"],"related":["bpca-prea","eu-paediatric-regulation","fdasia-2012","orphan-drug-act","eu-orphan-regulation"],"cancers":["paediatric-low-grade-glioma","dipg-dmg","neuroblastoma"],"sections":[],"technologies":[],"targets":[],"drugs":["tovorafenib","dabrafenib-trametinib","selpercatinib","larotrectinib"],"companies":["childrens-oncology-group","itcc"],"institutions":["fda-oce","ema","accelerate-platform"],"pathways":[],"terms":["orphan-drug","accelerated-approval"],"trials":["firefly-1","tadpole","pediatric-match"],"people":[],"bottlenecks":["b-rare-cancers","b-incentive-misalignment"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"category":"Regulation & policy","wikipediaChecked":"2026-09-22"},"route":"/terms/race-for-children-act/","neighbours":{"term":[{"id":"accelerated-approval","kind":"term","name":"Accelerated approval","route":"/terms/accelerated-approval/"},{"id":"fdasia-2012","kind":"term","name":"FDASIA 2012 and the origins of the expedited programmes","route":"/terms/fdasia-2012/"},{"id":"orphan-drug","kind":"term","name":"Orphan drug","route":"/terms/orphan-drug/"},{"id":"orphan-drug-act","kind":"term","name":"Orphan Drug Act 1983","route":"/terms/orphan-drug-act/"},{"id":"bpca-prea","kind":"term","name":"Paediatric drug laws: BPCA and PREA","route":"/terms/bpca-prea/"},{"id":"eu-orphan-regulation","kind":"term","name":"Regulation (EC) No 141/2000: EU orphan medicines","route":"/terms/eu-orphan-regulation/"},{"id":"eu-paediatric-regulation","kind":"term","name":"Regulation (EC) No 1901/2006: EU paediatric medicines","route":"/terms/eu-paediatric-regulation/"}],"cancer":[{"id":"dipg-dmg","kind":"cancer","name":"Diffuse midline glioma, H3 K27-altered (including DIPG)","route":"/cancers/dipg-dmg/"},{"id":"inflammatory-myofibroblastic-tumour","kind":"cancer","name":"Inflammatory myofibroblastic tumour (IMT)","route":"/cancers/inflammatory-myofibroblastic-tumour/"},{"id":"neuroblastoma","kind":"cancer","name":"Neuroblastoma (paediatric)","route":"/cancers/neuroblastoma/"},{"id":"paediatric-low-grade-glioma","kind":"cancer","name":"Paediatric low-grade glioma","route":"/cancers/paediatric-low-grade-glioma/"},{"id":"rare-childhood-cancers","kind":"cancer","name":"Rare cancers of childhood (NCI PDQ umbrella)","route":"/cancers/rare-childhood-cancers/"}],"drug":[{"id":"dabrafenib-trametinib","kind":"drug","name":"Dabrafenib + trametinib","route":"/drugs/dabrafenib-trametinib/"},{"id":"larotrectinib","kind":"drug","name":"Larotrectinib","route":"/drugs/larotrectinib/"},{"id":"selpercatinib","kind":"drug","name":"Selpercatinib","route":"/drugs/selpercatinib/"},{"id":"tovorafenib","kind":"drug","name":"Tovorafenib","route":"/drugs/tovorafenib/"}],"company":[{"id":"childrens-oncology-group","kind":"company","name":"Children's Oncology Group (COG)","route":"/companies/childrens-oncology-group/"},{"id":"itcc","kind":"company","name":"Innovative Therapies for Children with Cancer (ITCC)","route":"/companies/itcc/"}],"institution":[{"id":"accelerate-platform","kind":"institution","name":"ACCELERATE","route":"/institutions/accelerate-platform/"},{"id":"ema","kind":"institution","name":"European Medicines Agency","route":"/institutions/ema/"},{"id":"fda-oce","kind":"institution","name":"FDA Oncology Center of Excellence","route":"/institutions/fda-oce/"}],"trial":[{"id":"action-dmg","kind":"trial","name":"ACTION","route":"/trials/action-dmg/"},{"id":"firefly-1","kind":"trial","name":"FIREFLY-1","route":"/trials/firefly-1/"},{"id":"pediatric-match","kind":"trial","name":"NCI-COG Pediatric MATCH (APEC1621)","route":"/trials/pediatric-match/"},{"id":"tadpole","kind":"trial","name":"TADPOLE (CDRB436G2201)","route":"/trials/tadpole/"}],"bottleneck":[{"id":"b-incentive-misalignment","kind":"bottleneck","name":"Incentives reward me-too drugs and marginal gains","route":"/bottlenecks/b-incentive-misalignment/"},{"id":"b-rare-cancers","kind":"bottleneck","name":"Rare and paediatric cancers without markets","route":"/bottlenecks/b-rare-cancers/"}],"roadmap":[{"id":"paediatric-oncology-roadmap","kind":"roadmap","name":"Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first","route":"/roadmaps/paediatric-oncology-roadmap/"}]}}