The FDA Center for Tobacco Products mission is to protect Americans from tobacco-related disease and death by regulating the manufacture, distribution, and marketing of tobacco products and by educating the public, especially young people, about tobacco products and the dangers their use poses to themselves and others. To achieve this mission CTP performs science-based application review in addition to compliance outreach, enforcement, regulation and guidance formulation and other product regulation activities. CDISC has developed standard models, concepts, terminologies, data exchange formats and implementation and user guides to improve the quality, efficiency and cost effectiveness of clinical research processes from protocol through analysis and reporting. CDISC standards support interoperability and reusability and facilitate the application of artificial intelligence (AI) algorithms that can only be gained by analyses of large, pooled datasets. Machine-readable CDISC standards are available in Excel, JSON, RDF and multiple forms of XML. The Operational Data Model (ODM) XML standard used for data sharing, provenance, and archiving is also freely available. CDISC standards are required for regulatory submission of clinical trial data in the US, Japan and are accepted in EU and China. This presentation will discuss CTPs commitment to the development and implementation of standards to speed regulatory review and decision making, introduce CDISC and the suite of CDISC standards, briefly describe the global regulatory environment and provide an overview of the collaborative standards development project recently commenced to develop clinical data standards, new domain specifications, conformance rules and new terminology for tobacco studies. The presentation will conclude with a question-and-answer session.