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To legally market a new tobacco product, manufacturers must submit an application to FDA and receive a marketing authorization from FDA. When a new tobacco product To legally market a new tobacco product, manufacturers must submit an application to FDA and receive a marketing authorization from FDA. When a new tobacco product 

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All studies,

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serverIssue Tracker (JIRA)
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including studies on tobacco products, collect general information about a subject/participant. This section shows information typically collected in all studies, such as study disposition, demographic and subject characteristic information ( e.g., sex, age), information about prior tobacco product use, safety laboratory tests, and medical history. Most subject-level observations collected during the study should be represented according to 1 of the 3 SDTM general observation classes: Interventions, Events, or Findings.

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