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.
Topics to be addressed in the meeting include:
- 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.
This free, public meeting will feature presentations from FDA staff and expert panel discussions to provide information to improve public understanding of the application process, as well as assist those who are considering or preparing to submit marketing applications for tobacco products to FDA. The meeting is not intended to communicate any new policies or interpretations regarding tobacco product marketing applications and their review.
The meeting will also be webcast live, free of charge, but registration is required. After the meeting, we will post the archived webcast and complete transcripts on the meeting webpage as soon as they are available.
FDA – August 27, 2019.
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