FDA In Brief > FDA In Brief: FDA advances framework for enabling the study of new tobacco products as part of the agency’s ongoing commitment to improve the efficiency and effectiveness of tobacco product regulation

FDA In Brief > FDA In Brief: FDA advances framework for enabling the study of new tobacco products as part of the agency’s ongoing commitment to improve the efficiency and effectiveness of tobacco product regulation





FDA In Brief: FDA advances framework for enabling the study of new tobacco products as part of the agency’s ongoing commitment to improve the efficiency and effectiveness of tobacco product regulation



Today, the U.S. Food and Drug Administration issued a revised draft guidance, “Use of Investigational Tobacco Products,” intended to assist tobacco product manufacturers, academic institutions and institutional review boards studying tobacco products. Among other things, it outlines the kind of information the agency intends to consider in making enforcement decisions regarding the use of investigational tobacco products, including potential human subject protection concerns or other impacts on public health. This revised draft guidance is part of the agency’s work on itscomprehensive plan for tobacco and nicotine regulation, in which the FDA committed to ...