1. FDA. Project Orbis. https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis.
2. GOV.UK. Guidance on Project Orbis. https://www.gov.uk/guidance/guidance-on-project-orbis.
3. FDA. New Drug Application (NDA). https://www.fda.gov/drugs/types-applications/new-drug-application-nda.
4. Australian Government Department of Health Therapeutic Goods Administration. Prescription medicines registration process. https://www.tga.gov.au/prescription-medicines-registration-process.
5. Government of Canada. Guidance Document: The Management of Drug Submissions and Applications. https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/management-drug-submissions/industry/document.html.