A new Tobacco Control supplement showcases the PhenX (consensus measures for Phenotypes and eXposures) initiative to identify common measures and data elements for use in tobacco regulatory research. The papers highlight the measurement collections in the PhenX Toolkit that was established for use in tobacco regulatory research, and provides investigators a better understanding of the purpose and scope of project. It also allows investigators to cite support for their use of the measures in grant applications and publications.
Resources for Researchers
Explore databases and tools for research to support the regulation of tobacco and tobacco products.
A catalog of recommended standard measures of phenotypes and environmental exposures for use in biomedical research. This includes common data elements for tobacco regulatory research.
Learn more about the PhenX Tobacco Regulatory Project and how these measures were identified, selected, and approved. Contact Dr. Kay Wanke, Deputy Director, TRSP/OD/NIH, for more information.
Nicotine research cigarettes (NRC) available to research investigators.
Access to information about active research projects in the FDA Center for Tobacco Products research portfolio.
Ongoing and timely information about emerging public health issues in smoking and tobacco use control from the National Cancer Institute.
Regulatory Research Information
This guidance will assist investigators who are seeking to request Investigational Tobacco Products (ITP) authorization or information to determine whether an ITP is needed when administering tobacco products to human study participants.
Answers to common questions about clinical studies of e-cigarettes examining a potential therapeutic purpose (e.g., smoking cessation), which may require an investigational new drug application. Such studies are not funded through TRSP.
Addresses the importance of tobacco research, research advances, funding opportunities, and ways to use the research.
Video interviews with leading researchers in tobacco regulatory research who share their work and discuss its importance to public health.
Tobacco Regulatory Science: Research To Inform Regulatory Action at the Food and Drug Administration’s Center for Tobacco Products
Clarifies the definition and role of regulatory science and describes the types of research efforts that will inform the FDA’s public health framework for tobacco product regulation.