Online Program

Use of Registries to Assess Premarketing Drug Safety for Regulatory Decision-Making (303499)

*Clara Y Kim, US Food and Drug Administration 

Keywords: real-world evidence, premarketing safety, registry

The 21st Century Cures Act, signed into law in 2016, is designed to accelerate medical product development by modernizing clinical study designs. This modernization includes using real-world evidence for regulatory decision making. This talk will focus on study design issues to consider when using registries to assess premarketing drug safety--- data source, comparator selection, outcome ascertainment and confounding control. We will include an example and discuss the benefits and drawbacks of using registries to assess premarketing drug safety.