Today the FDA posted new potential guidance for the industry and it is now open for commenting beginning tomorrow. This new potential guidance gives a strong outline for Perception and Intention Studies. Per the FDA’s definition “TPPI studies are studies that can be used to assess, among other things, individuals’ perceptions of tobacco products, understanding of tobacco product information, and intentions to use tobacco products.”
The guidance goes on to address the different steps in compiling a TPPI as well as stating that nothing in this guidance if passed is legally enforceable merely that the FDA is making recommendations on how these studies should be conducted in correlation with the applications. The applications this guidance would be relevant to in correlation to the studies would be Modified Risk Tobacco Products Applications, Premarket Tobacco Applications, or a Substantial Equivalence Report.
In the proposed guidance some recommendations that are listed right off the top in correlation to the studies are using the best practices specific to the study design and method the study was employed preferably that have either been written or published by well established social or behavioral scientific organizations or written by authors who have demonstrated scientific expertise in the type of method or design of the study. As well as recommending that if you are using the study as support for an application for more than one product you should include each product in the study when feasible and if no feasible you should pick the products based on the rationality that describes why based off these products it can be generalized for the remaining products.
The proposed guidance goes on to list different types of study methods and correlations for those study methods as well as addressing study hypotheses. It is the FDA’s strong recommendation that you develop study aims prior to conducting the study as well as developing specific hypotheses that can be separated into primary and secondary to create statistical data for analysis.
They finish up the guidance by stating modes of data collection, common informational biases based on different modes of collecting data, and recommendations for writing and drawing conclusions from the data. For a fully comprehensive breakdown of the proposed guidance, what it means for your PMTA application, and how to go about submitting amendments if needed call North Guide today at (909)635-6588