Join FDA on Oct. 28-29, 2019, at the agency’s White Oak Campus in Silver Spring, Md. to learn about the policies, processes, and general scientific principles related to tobacco product marketing applications, with a focus on deemed tobacco products such as cigars, waterpipes, and electronic nicotine delivery systems (ENDS), including e-liquids and electronic cigarettes.
- Overview of the tobacco product marketing application types, including substantial equivalence (SE) reports, exemption from substantial equivalence requests, and premarket tobacco product applications (PMTAs)
- Information that should be included in a tobacco product marketing application
- Administrative processes involved in the submission and review of a tobacco product marketing application
- Other topics relevant to the submission of tobacco product marketing applications, including communications between FDA and industry during an application review process, use of tobacco product master files, as well as electronic submission resources and tools.
FDA – August 27, 2019.