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FDAs MRTP review framework is informed by its March 2012 draft guidance, Modified Risk Tobacco Product Applications , which remains FDAs operative guidance on the content and organization of MRTP applications and calls for a broad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

Retrieved October 1, 2019