On August 27th, 2019 the FDA announced a public meeting to discuss preparing marketing applications for covered tobacco products. In case you haven’t seen it, here’s the information. If you are an industry stakeholder we urge you to sign up and submit questions you may have to be taken into consideration for the meeting. Click here to see the email in a web browser.
Learn About Preparing Marketing Applications for Deemed Tobacco Products—Public Meeting, Oct. 28-29, 2019
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.
- Application development and submission, including pre-submission meetings and use of tobacco product master files
- Scientific content and evaluation of PMTAs
- Scientific content and evaluation of exemption requests and SE reports
- Preparation of electronic submissions including FDA resources and tools available to support application submission