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This example will need to be updated following recent developments and consultation with CDISC ISMT. Current examples illustrating this approach can be found in the Sandbox here.

https://www.sciencedirect.com/science/article/pii/S004060311930752X


This is an example for the required tobacco product characterization, property description, and design parameter information in an FDA marketing application for one type of tobacco product Electronic Nicotine Delivery System (ENDS) (Vapes). There are many more and various types of tobacco products, and their parameters can be found in the in the FDA final rule and guidance documents for tobacco product Premarket Authorization (PMTA) and Substantial Equivalence pathways. The applicant submitting for SE and PMTAs may include test data to include test protocols, quantitative acceptance criteria, data sets, and summary of results as applicable for these parameters.

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