Causal Inference Methodology and Its Application in Evaluating Efficacy and Safety of Drugs

Project Overview Causal inference, originally developed for epidemiology studies, considers statistical methods for estimation and inference related to causal effects; it applies to both observational and randomized studies. Insight directed the research, analysis, and training on statistical issues related to establishing a causal link between reported adverse events and prior treatment with an HIV drug/medical[...]

Project Overview This evaluation identified, described, and evaluated the strengths and limitations of data sources that potentially could be included in the Food and Drug Administration’s (FDA) Sentinel Initiative. FDA’s Sentinel System was designed for near real-time monitoring of the postmarket performance of regulated medical products. This phase of the Sentinel work aimed to assess[...]

Project Overview This project developed and updated four independent models for the Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition (CFSAN). The models investigated the impacts of FDA regulations on small entities, in compliance with the Regulatory Flexibility Act. Small business entities have fewer resources to devote to regulatory compliance and[...]

Project Overview For more than a decade, Take Time to Care (TTTC)—the major outreach initiative for the Food and Drug Administration’s (FDA) Office of Women’s Health (OWH)—has been a leader in providing lifesaving information to women across the United States. TTTC recognizes the many roles of American women as family caretakers, educators, nurturers, and leaders[...]