👉 The FDA's mathematical approach, often referred to as FDA Math, integrates statistical and mathematical methodologies to enhance regulatory decision-making in the pharmaceutical and medical device industries. It emphasizes the use of data-driven models to assess drug efficacy, safety, and risk-benefit profiles, enabling more informed and efficient regulatory evaluations. FDA Math leverages advanced statistical techniques such as Bayesian analysis, survival analysis, and machine learning to interpret complex clinical trial data, optimize trial designs, and predict outcomes. This approach aims to reduce uncertainty, streamline the approval process, and ensure that regulatory decisions are grounded in robust quantitative evidence, ultimately benefiting patients by accelerating access to safe and effective medical products.
