FDA releases final guidance on tobacco product research

FDA releases final guidance on tobacco product research
FDA releases final guide to help applicants design and conduct tobacco product intention studies.

On August 23rd, the U.S. Food and Drug Administration (FDA) released its final guidelines on guiding research into tobacco product intentions (TPPI).

Tobacco Products: Principles for Design and Implementation of Tobacco Product Intention Studies" is aimed at assisting applicants in completing studies related to the design and risk assessment of Modified Risk Tobacco Products (MRTP), Tobacco Product Marketing Applications (PMTA) including TPPI studies, or Equivalent Reports (SE) before their release to the market.

The FDA has stated that TPPI research can be used to assess individuals' views on tobacco products, understanding of tobacco product information (such as labeling and modified risk information), and intentions to use tobacco products. These studies provide crucial information during product application reviews, and this guide offers recommendations on how to conduct such research.

The Final Guidance addresses several scientific issues that applicants need to consider when designing and conducting studies on Tobacco Product Pathways of Introduction (TPPI) to support the application of tobacco products.

Developing research objectives and hypotheses, designing quantitative and qualitative research, selecting and adjusting measures of learning structure, determining research outcomes, selecting and proving research samples, and analyzing research results.

The FDA has announced that the purpose of this guidance document is to provide clarity on existing regulatory requirements for applicants. According to the agency's statement, "FDA guidance documents, including this one, should be considered as recommendations for consideration, unless specific regulatory or statutory requirements are referenced.


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