Study data standards are a critical factor in improving the overall effectiveness and efficiency of the regulatory review process. This session will provide an overview of FDA's commitment to the use of open, consensus-based data standards that will facilitate the efficient review of regulatory submissions. The discussion will include topics on the data standards strategy, data governance structure and planned guidances. In addition, the session will discussion data standards issues and tools from the reviewer's perspective. Lastly, an industry perspective on data standards will be provided.