Meeting
Event Title
Premarket Applications: Opportunities for Stakeholder Engagement - A Public Meeting
October 23 - 24, 2023
The meeting is free and open to the public.
- Date:
- October 23 - 24, 2023
- Day1:
- - ET
- Day2:
- - ET
- Organized By:
On this page:
- October 23, 2023 - Day 1 Presentations, Transcript and Agenda
- October 24, 2023 - Day 2 Presentations, Transcript and Agenda
- Meeting Objective
- Contact for Questions
October 23, 2023 - Day 1 Presentation Recording
Agenda
- Welcome Address and Remarks: Brian King, PhD, MPH - FDA Center for Tobacco Products
- Overview of the Meeting: Avena Russell, MS - CDR
Session 1: PMTA: Current Status and Looking Forward
- Premarket Tobacco Product Application (PMTA) Overview – Huda Dawood, BS
- Program Status on PMTAs – Eric Cruz, BS
Session 2: Required Content and Format of PMTAs
- PMTA Acceptance – Lauren DeBerry, MPH
- Tobacco Product Master Files – Sequoia Bacon, MHA
- CTP and CDISC Tobacco Data Standards Development – Chrissie Cai, MS
- Electronic Submissions Lessons Learned & Common Errors – Deborah Sholtes, MS
- Product Form Validator Tool for PMTA 4057(b) Form – Sheryl Wood MPH and Fran Weiss, BS
Session 3: Substantial Equivalence: Current Status and Looking Forward
October 24, 2023 - Day 2 Presentation Recording
Agenda
Session 4: FDA Review – Product Characterization
- Best Practices for Submitting Complete Ingredient and HPHC Information in PMTAs – Stephanie Daniels, PhD
- Extractables and Leachables Evaluation – Rachel Lerebours, PhD and Kristin Wurcel, PhD
Session 5: FDA Review – Behavioral Evidence
- Recommendations for Abuse Liability Studies – Mollie Miller, PhD
- Demonstrating Adult Benefit for Flavored ENDS PMTAs – Apostolos Alexandridis, PhD, MPH
Session 6: FDA Review – Toxicology
- Hazard Identification: Genetic Toxicology Assessment for PMTAs – Challenges and Limitations – Mamata De, PhD
- Considerations in Assessing Relative Hazards, Exposures, and Risks between ENDS and other tobacco products – Jonathan Fallica, PhD and Mary Irwin, PhD
Session 7: Questions and Answers with Office of Science Staff
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
- 1-877-287-1373
- AskCTP@fda.hhs.gov