Developments in Quantitative Drug Safety Evaluation, Perspectives from a Regulator
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*Mark Steven Levenson, CDER/FDA 

Keywords: safety, meta-analysis, observational studies, Sentinel

In the last 10 years, several internal and external events, initiatives, and actions have increased the resources and efforts devoted to the evaluation of drug safety in both the premarket and post-market life-cycles of drugs at the Center for Drug Evaluation and Research (CDER). Biostatistics at CDER has had a large role in these efforts. Biostatistics support in quantitative drug safety has included the design and analysis of (1) large outcome trials, (2) meta-analyses, and (3) observational studies. The talk will present examples in these areas. The talk will also describe recent initiatives including Sentinel, the development of the meta-analysis for safety guidance, and the guidance for establishing the cardiovascular safety of diabetic therapies. Finally, the talk will discuss future directions and challenges in the area of quantitative drug safety.