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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 | ||
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DI = TO for Tobacco Product Identifiers and Descriptors SPDEVID = SPTOBID for Sponsor Tobacco Product Identifier DO/DU = LB = Tobacco Product Testing (PT) - [Would Findings be better?] |
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.
Tobacco Product Identifier (TO) (similar to Device Identifiers (DI)) is a study reference dataset that provides a mechanism for uniquely identifying a tobacco product. The primary purpose of this dataset is to provide a list of the products used in an application or study and to provide identifying information for each product, such as product category type, manufacturer, properties, product name, etc., as applicable. All identifying information is grouped by the Sponsor Tobacco Product Identifier (SPTOBID), a consistent variable, that is available for use in other domains where data pertaining to the product may be found.
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