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 agencys 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
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