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For instance, 2 large meta-analyses were unable to depict an effect of smoking status on response to infliximab [22,23], and smoking, if anything, may have a positive impact on thiopurine metabolism and related treatment response

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FDAs MRTP review framework is informed by its March 2012 draft guidance, Modified Risk Tobacco Product Applications , which remains FDAs operative guidance on the content and organization of MRTP applications and calls for a broad scientific showing addressing, among other things, product characterization, nonclinical and clinical evidence, consumer perception and understanding, actual-use behavior, population-level modeling, proposed labeling and advertising, and postmarket surveillance

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