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This example has been updated according to the approached discussed on the team call on 1/17. Additionally, we have simplified the Tobacco Product Identifiers and Descriptors (TO) domain by using parameters (TOPARM) instead of tests (TOTEST) |
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THIS EXAMPLE IS UNDER RECONSTRUCTION FOLLOWING DISCUSSIONS ON THE TEAM CALL 17 JAN. Updates include: 1) Simplifying PD.xpt to one record per parameter and (2), simplifying TO.xpt to a parameter-based dataset |
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 SNUS. 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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