Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies; Guidance for Industry; Availability

Resumo

The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry entitled "Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies." The final guidance provides information intended to assist applicants design and conduct tobacco product perception and intention (TPPI) studies that may be submitted as part of a modified risk tobacco product application (MRTPA), a premarket tobacco product application (PMTA), or a substantial equivalence (SE) report. The final guidance discusses a variety of scientific issues applicants may want to consider as they design and conduct TPPI studies.