FDA CTP Premarket Stakeholder Meeting Presentations and Overview

FDA Center for Tobacco Products held a Premarket Stakeholder Engagement Meeting on October 23 & 24, 2023. I put together a list of topics covered and a link to the full set of presentations. Day 1 focused on mostly administrative and compliance aspects of applications while Day 2 was focused on the science behind the application process. There is a wealth of quality information in these presentations. It seems like it's the culmination of many years of work across many disciplines at CTP. It will serve as a great reference point in future for driving forward the science and evidence needed to gain market authorization. Link to presentations.

Day 1

• Background - Slide 6

• PMTA Review Process - Slide 10

• Helpful PMTA Resources - Slide 27

• Program Status on PMTAs - Slide 29

• PMTA Acceptance - Slide 48

• Tobacco Product Master Files (TPMF) - Slide 81

• CTP and CDISC Tobacco Data Standards  Development - Slide 107

• Electronic Submissions Lessons Learned and Common Errors - Slide 132

• Product Form Validator Tool for PMTA 4057(B) Form - Slide 172

• Updates on Substantial Equivalence Reports (SE Reports) - Slide 214

Day 2

• Best Practices for Submitting Complete Ingredient and HPHC Information in PMTAs - Slide 247

• Extractables and Leachables Evaluation - Slide 270

• Recommendations for Abuse Liability Studies - Slide 301

• Demonstrating Adult Benefit for Flavored ENDS PMTAs - Slide 317

• Hazard Identification: Genetic Toxicology Assessments for Premarket Tobacco Product Applications (PMTAs) - Challenges and Limitations - Slide 343

• Considerations in Assessing Relative Hazards, Exposures and Risks Between ENDS and other Tobacco Products - Slide 365