Tobacco

FDA Releases New Resource to Facilitate Tobacco Product Research and Scientific Review

Tobacco Implementation Guide serves as a resource for the collection, tabulation, analysis and exchange of product data for submissions
FDA
Photograph: Shutterstock

The Food and Drug Administration’s Center for Tobacco Products (CTP), in partnership with the Clinical Data Interchange Standards Consortium (CDISC), has released a new resource to help facilitate tobacco product research and scientific review.

The Tobacco Implementation Guide (TIG) includes data standards that can help “optimize scientific accuracy and review efficiency,” the FDA said.

Use cases addressed in the TIG include:

  • Product prescription, which refers to concepts used to characterize tobacco products.
  • Nonclinical, which refers to concepts used to identify potential risks and effects on biological processes for tobacco products via in vitro and in vivo nonclinical studies. 
  • Product impact on individual health, which refers to concepts used to assess the impact of tobacco products on individuals.  
  • Product impact on population health, which refers to concepts used to assess the impact of tobacco products on populations of individuals.

Created by a multidisciplinary team from CTP, tobacco industry stakeholders, and CDISC, the guide also includes public review comments and resolutions to ensure transparency and show implementers how comments were addressed, the FDA said.

“CDISC created the Tobacco Implementation Guide to serve as a comprehensive resource for the collection, analysis, and exchange of tobacco product data for submissions to CTP, including tobacco product applications and research findings,” the FDA said.

Examples of tobacco product application submissions include Premarket Tobacco Product Applications (PMTAs), Substantial Equivalence (SE) reports, and Modified Risk Tobacco Product (MRTP) applications. Examples of research include epidemiology studies, toxicology reports, and behavioral studies.

TIG implements several data models, including clinical data acquisition standards harmonization, study data tabulation model, and analysis data model, the FDA said.

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