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  • thuytienlecao replied to the topic "What is Risk-benefit analysis ?"6 years, 1 month ago

    I would like elaborate @merzkrashed‘s point about the FDA article “Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications”. When determining risk, the FDA assessing the severity, type, frequency, and length of harmful…   Read more»