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TSRC, Tob. Sci. Res. Conf., 2023, 76, abstr. 41

FDA-CTP and CDISC develop tobacco related standards to achieve efficiencies for all stakeholders

CAI C.(1); CONNOLLY C.
(1) FDA Center for Tobacco Products, Beltsville, MD, USA; (2) CDISC, Austin, TX, USA

The FDA Center for Tobacco Product’s 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.

This presentation will describe work as part of the collaborative project commenced by CTP and CDISC to develop nonclinical and clinical data standards for tobacco studies to speed regulatory review and decision making. Innovative approaches to standardization developed as part of this project will be discussed and include a hybrid implementation guide structure, new domains, and terminology.