1. EMA (2017) Results of juvenile animal studies (JAS) and impact on anti-cancer medicine development and use in children: project report. https://www.ema.europa.eu/en/documents/scientific-guideline/results-juvenile-animal-studies-jas-impact-anti-cancer-medicine-development-use-children_en.pdf. Accessed 19 Feb 2021
2. FDA (2010) Guidance for industry: nonclinical evaluation for anticancer pharmaceuticals. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/s9-nonclinical-evaluation-anticancer-pharmaceuticals. Accessed 24 Feb 2021
3. FDA (2015) FDA summary review for Unituxin (dinutuximab, BLA 125516). Dated 10 Mar 2015. Available at: drugs@fda, https://www.accessdata.fda.gov/scripts/cder/daf/
4. FDA (2018a) FDA summary review for Vitrakvi (larotrectinib, NDA 210861). Dated 26 Nov 2018. Available at: drugs@fda, https://www.accessdata.fda.gov/scripts/cder/daf/
5. FDA (2018b) Guidance for industry: nonclinical evaluation for anticancer pharmaceuticals: questions and answers. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/s9-nonclinical-evaluation-anticancer-pharmaceuticals-questions-and-answers. Accessed 24 Feb 2021