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          Premarket Applications: Opportunities for Stakeholder Engagement - A Public Meeting - 10/23/2023CTP Newsroom Meeting
    Event Title
              Premarket Applications: Opportunities for Stakeholder Engagement - A Public Meeting


                  October 23 - 24, 2023

  Scheduled

             The meeting is free and open to the public.
  
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October 23 - 24, 2023   

 
 
        
                
                                      Day1: 
              Mon, Oct 23 9:00 AM
 - 4:30 PM
 ET
            
                      Day2: 
              Tue, Oct 24 8:30 AM
 - 4:00 PM
 ET
                
  Organized By: 
      Organizer
          Center for Tobacco Products
          Food and Drug Administration

 







**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 QuestionsOctober 23, 2023 - Day 1 Presentation Recording



October 23, 2023 - Day 1 Presentations Transcript and Agenda
	Transcript

**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**

Updates on Substantial Equivalence Reports – Kris VanAmburgClosing Remarks – Todd Cecil, PhD

October 24, 2023 - Day 2 Presentation Recording



October 24, 2023 - Day 2 Presentations Transcript and Agenda
	Transcript

**Agenda**

Welcome Address and Remarks – Matthew Farrelly, PhD
	Brief Overview of Meeting – CDR Avena Russell**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**

Closing Remarks – Benjamin Apelberg, PhD

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 healthFDA 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

                                                                                  Content current as of:
      12/21/2023
         
                   
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