FDA Announces Public Meeting To Discuss Preparing Marketing Applications

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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.

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.
BECOME A PANELIST: We are currently accepting nominations for panelists interested in addressing the following topics related to tobacco product marketing application review:
  • 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
To be considered, please identify the topic(s) you would like to discuss and provide a one-page biography that supports your expertise on the topic(s) being presented, including positions(s) currently held. Please send nominations to workshop.CTPOS@fda.hhs.gov through Sept. 13, 2019.
REGISTER TO ATTEND: You must register to attend the meeting no later than Sept. 30, 2019. Both in-person seating and webcast viewership are limited, so early registration is recommended. Onsite registration may be allowed if space is available. FDA may limit the number of registrants from a single organization, as well as the total number of participants, if registration reaches full capacity.
Additional details, including the agenda and webcast link, will be made available before the meeting. See the meeting webpage for the latest information.

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