FDA "Grids" for More Transparent Risk-Benefit Decision
This article was originally published in RPM Report
Executive Summary
FDA is designing a five-item grid as a management tool to explain its risk-benefit decisions in a new more concise format. The model that it has created as a working template confirms a truism about its drug approval tendencies that industry has suspected for years: the baseline for FDA approval is a high-rating of the severity of the disease being treated and the medical need for the product.
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