The Food and Drug Administration has announced that it will host a public meeting on Oct. 23 and Oct. 24, with the topic centering around Premarket Tobacco Product Applications (PMTAs) and Substantial Equivalence Reports (SE Reports).
The meeting will aim to provide information and assist applicants with problems that have been observed in reviewing applications over the past three years.
FDA has stated that the meeting will, “provide an opportunity for stakeholder engagement and will improve public understanding and assist persons considering submitting SE Reports or PMTAs.”
Topics that will be covered include:
- 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
- Review issues related to product characterization, nonclinical science, abuse liability and population health
FDA will present information about the SE and PMTA process including process improvements, and observations that may inform further improvements in submissions and the review process. FDA will seek feedback from the public and have panels of FDA representatives to discuss various topics.
The meeting will not communicate any new policies or interpretations regarding tobacco product marketing applications and their review.
The meeting will kick off at 9:00 a.m. Oct. 23 and will continue at 8:30 a.m. Oct. 24. It will take place in-person with a virtual option.
