1. European Medicines Agency (2011), Work package 2 report: applicability of current tools and processes for regulatory benefit‐risk assessment, In: Benefit‐risk methodology project. Report No.: EMA/549682/2010. http://www.ema.europa.eu/docs/en_GB/document_library/Report/2010/10/WC500097750.pdf.
2. US Food and Drug Administration (2013). Structured approach to benefit-risk assessment in drug regulatory decision-making. Draft PDUFA V implementation plan. Fiscal Years 2013–2017. http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM329758.pdf.
3. Angelis A, Phillips L. Structured decision-making in drug regulation at the FDA and EMA. Br J Clin Pharmacol. 2021;87(7):395–405.
4. Levitan BS, Andrews EB, Gilsenan A, Ferguson J, Noel RA, Coplan PM, Mussen F. Application of the BRAT framework to case studies: observations and insights. Clin Pharmacol Ther. 2011;89(2):217–24.
5. US Food and Drug Administration (2019). Factors to consider when making benefit-risk determinations in medical device premarket approval and De Novo classifications. Guidance for industry and food and drug administration staff. https://www.fda.gov/media/99769/download.