1. IMI PROTECT (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium). https://protectbenefitrisk.eu/
2. Benefit Risk Action Team Software Tool. https://www.cirs-brat.org/
3. US Food and Drug Administration. Benefit-risk framework review documents, Integrated Review. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
4. US Food and Drug Administration. Benefit–risk assessment for new drug and biological products. Guidance for industry. Draft Guidance. 2021. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/benefit-risk-assessment-new-drug-and-biological-products
5. Benefit-risk balance for medicinal products. CIOMS Working Group XII report. Geneva, Switzerland: Council for International Organizations of Medical Sciences (CIOMS), Draft. https://cioms.ch/working-groups/working-group-xii/. Accessed 12 June 2023.