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  4. Premarket Applications: Opportunities for Stakeholder Engagement - A Public Meeting - 10/23/2023
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Meeting | In Person

Event Title
Premarket Applications: Opportunities for Stakeholder Engagement - A Public Meeting
October 23 - 24, 2023


The meeting is free and open to the public.

October 23 - 24, 2023
- ET
- ET


On this page:

October 23, 2023 - Day 1 Presentation Recording

October 24, 2023 - Day 2 Presentation Recording

Meeting Objective 

This meeting provided information on the agency’s expectations for substantial equivalence reports (SE Reports) and premarket tobacco product applications (PMTAs) and information to assist applicants with avoiding problems that CTP had observed in reviewing applications over the past three years. The meeting provided an opportunity for stakeholder engagement to improve public understanding and assist persons considering submitting SE Reports or PMTAs.  

Topics that were addressed during the meeting included: 

  • Overview of the SE and PMTA process, changes since the SE and PMTA final rule implementation, and program status 
  • Required content and format for PMTAs 
  • Reviewed issues related to product characterization, nonclinical science, abuse liability, and population health  

FDA presented information about the SE and PMTA process including process improvements, and observations that may inform further improvements in submissions and the review process. FDA sought feedback from the public and had panels of FDA representatives to discuss various topics.  

The meeting did not communicate any new policies or interpretations regarding tobacco product marketing applications and their review.  

Contact for Questions 


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