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

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

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

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Evaluation of Potential Data Sources for Animal Drugs Used in Veterinary Medicine

Project Overview The overall goals of this evaluation were to identify, describe, and evaluate the strengths and limitations of existing 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[...]

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Small Business CFSAN Models

Project Overview The purpose of this project was to develop and update 4 independent models for the Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition (CFSAN). The models were designed to investigate the impacts of FDA regulations on small entities, in compliance with the Regulatory Flexibility Act (RFA). These small business[...]

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Take Time to Care Within the Hispanic Community

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 multiple roles of American women as family caretakers, educators, nurturers, and leaders,[...]

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