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FDA published a new report calling for new drug regulatory decision-making paradigm for benefit:risk assessments. The report rejects the quantitative-only approach to regulation that some have advocated, saying such an approach would be counterproductive to the agency's goals of making the decision-making process clearer and more predictable.
FDA's report is an attempt to lay the groundwork for answering questions about how the agency defines its own benefit:risk paradigm.
Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision-Making