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3. Food and Drug Administration (FDA). Factors to consider regarding benefit-risk in medical device product availability, compliance, and enforcement decisions. Guidance for Industry and Food and Drug Administration Staff. US Department of Health and Human Services, Food and Drug Administration Center for Devices and Radiological Health (CDRH). https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm506679.pdf. Published 2016. Accessed June 26, 2018.
4. European Medicines Agency (EMA). Reflection paper on benefit-risk assessment methods in the context of the evaluation of marketing authorisation applications of medicinal products for human use. Committee for Medicinal Products for Human Use (CHMP); EMEA/CHMP/15404/2007. http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2010/01/WC500069634.pdf. Published 2008. Accessed June 26, 2018.
5. European Medicines Agency (EMA). Information on benefit-risk of medicines: patients’, consumers’ and healthcare professionals’ expectations. Patients’ and Consumers’ Working Party (PCWP) and the Healthcare Professionals’ Working Group (HCP WG); EMEA/40926/2009. http://www.ema.europa.eu/docs/en_GB/document_library/Other/2009/12/WC500018433.pdf. Published 2009. Accessed June 26, 2018.