Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies; Draft Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies." The draft guidance provides information intended to assist applicants design and conduct tobacco product perception and intention (TPPI) studies that may be submitted as part of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 The draft guidance is intended to discuss a variety of scientific issues applicants may want to consider as they design and conduct TPPI studies.