BLOG: FDA shares 5-year blueprint for designing more structured risk-benefit analysis

On March 8, the FDA published in the Federal Register a notice of the availability of its draft five-year plan describing the Agency’s approach to developing and implementing a structured framework for benefit-risk assessment.Publication of this plan fulfills one of FDA’s obligations under the Food and Drug Administration Safety and Innovation Act (FDASIA). The plan sets out FDA’s initial benefit-risk framework, which incorporates key decision factors of Analysis of Condition, Current Treatment Options, Benefit, Risk and Risk Management.

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