The FDA makes decisions about imminent risks to the blood supply and evaluates potential risk mitigation using a benefit-risk approach in order to inform policy. How is this done? What parameters structure these decisions and what are the processes invoked to incorporate them? This session will describe FDA’s structured regulatory decision-making process using real benefit-risk assessment examples and provide opportunities for audience participation (ARS). Speakers will engage the audience by describing how results are incorporated into final guidance and final rules. Audience challenge questions will be included. Finally, there will be a demonstration of a risk assessment tool developed by the FDA, BRisk or BenefitRisk, to show how infectious disease risks can be modeled for better understanding of potential disease exposures.
Explain the parameters governing the FDA’s process for evaluating benefit and risk of changes to blood safety policy.
Describe two examples of the benefits and risks evaluated for incorporation into FDA policy decisions.
Summarize how the BRisk tool can be used to evaluate emerging infectious disease risk.