New U.S. FDA Draft Guidance for Perception Studies
The U.S. Food and Drug Administration (FDA) has released a draft guidance for tobacco product perception and intention (TPPI) studies. The studies must be submitted as part of a modified risk tobacco product application (MRTP), a premarket tobacco product application (PMTA) or a substantial equivalence report (SE Report).
The guidance is aimed at helping applicants design and conduct the studies that can be used to assess, among other things, individuals’ perceptions of tobacco products, understanding of tobacco product information (e.g., labeling, modified risk information), and intentions to use tobacco products.
It is possible for a TPPI study to also include an actual use component (e.g., an actual product utilized in a simulated use setting or a real environment of use); however, a discussion of actual use research is beyond the scope of this draft guidance, according to the FDA.
This draft guidance addresses the following scientific issues for applicants to consider as they design and conduct TPPI studies to support tobacco product applications:
- Developing TPPI study aims and hypotheses
- Designing quantitative and qualitative TPPI studies
- Selecting and adapting measures of TPPI study constructs
- Determining TPPI study outcomes
- Selecting and justifying TPPI study samples
- Analyzing TPPI study results
The administration is accepting public comments related to the draft guidance through Dec. 28. The application deadline was Sept. 9 for deemed new tobacco products that were on the market as of Aug. 8, 2016, and the FDA said it intends to make a public list of what products were submitted on time.
