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  4. Deemed Tobacco Product Applications - A Public Meeting - 10/28/2019 - 10/29/2019
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Meeting

Event Title
Deemed Tobacco Product Applications - A Public Meeting
October 28 - 29, 2019

Scheduled
Date:
October 28 - 29, 2019
Time:
8:30 AM - 4:30 PM ET
Location:
Event Location
White Oak Campus: The Great Room
Conference Center

10903 New Hampshire Ave
Building 31, Room 1503
Silver Spring, MD 20993
United States


Organized By:

On this page:


Meeting Objective

This meeting was intended to provide information on the agency’s process for tobacco product application review with a particular focus on deemed tobacco products (e.g., cigars, waterpipe, and Electronic nicotine Delivery Systems (ENDS) including e-liquids and electronic cigarettes) including product review policies, procedures, and general scientific principles.


Agenda and Presentations

Transcripts

October 28, 2019

8:30 am (video)
Welcome Address—Matthew Holman, Ph.D., CTP Office of Science 
Opening Remarks—David Graham, M.P.A., NJOY
Overview of the Meeting—Anne Radway, M.S., CTP Office of Science 

8:45 am – Communications & IT Resources

10:00 am – Panel Discussion on Communications and IT Resources (video begins at 1:09:49)
Moderator: Anne Radway, M.S., CTP Office of Science
Panelists: Leanne Campbell, Ph.D., RAI Services, Co.; Anuschka Merson, M.S., ITG Brands, LLC; Crystal Allard, CTP Office of Science; Cristi Stark, M.S., CTP Office of Science

11:00 am – Premarket Tobacco Product Applications (PMTAs)—Review Process and Resources

1:15 pm – Application-Related Inspections (video)
Chad Burger, M.S., CTP Office of Compliance and Enforcement 

1:45 pm – Panel Discussion on PMTA Review Process (video begins at 13:25)
Moderator: Anne Radway, M.S., CTP Office of Science
Panelists: Kevin Burd, North America Nicotine; Michael Ogden, RAI Services, Co.; Cristi Stark, M.S., CTP Office of Science; Lillian Ortega, M.P.H., CTP Office of Compliance and Enforcement

2:30 pm – Premarket Tobacco Product Applications (PMTAs) Scientific Content 

3:45 pm – Closing Remarks
Anne Radway, M.S., CTP Office of Science

 

October 29, 2019

8:30 am – Welcome (video)
Todd Cecil, Ph.D., CTP Office of Science

8:45 am – PMTAs Scientific Content (Continued) (video begins at 5:35)
Lessons Learned from PMTA Reviews—Hans Rosenfeldt, Ph.D., CTP Office of Science

9:30 am – Panel Discussion on PMTA Scientific Content (video begins at 36:22)
Moderator: Todd Cecil, Ph.D., CTP Office of Science
Panelists: Jason Flora, Ph.D., Altria; Elaine Round, Ph.D., RAI Services, Co.; Steve Seiferheld, M.S., Venebio; Iilun Murphy, M.D., CTP Office of Science; Emily Talbert, M.P.H., CTP Office of Health Communication and Education; Hans Rosenfeldt, Ph.D., CTP Office of Science

10:45 pm – Substantial Equivalence (SE) Scientific Content and Exemption Requests 

12:30 pm – Substantial Equivalence (SE) Scientific Content and Exemption Requests (Continued)

1:30 pm – Panel Discussion on SE Scientific Content (video begins at 51:00)
Moderator: Todd Cecil, Ph.D., CTP Office of Science
Panelist: Christopher Junker, Ph.D., RAI Services, Co.; Gerald Long, M.S., ITG Brands LLC; Colleen Rogers, Ph.D., CTP Office of Science; Laurie Sternberg, J.D., CTP Office of Compliance and Enforcement; Matthew Walters, Ph.D., CTP Office of Science; Rosanna Beltre, M.P.H., CTP Office of Science

2:15 pm – Q&A Session (video)
Moderator: Todd Cecil, Ph.D., CTP Office of Science
Panelists: Glen Jones, PhD., CTP Office of Science; Iilun Murphy, M.D., CTP Office of Science; Cristi Stark, M.S., CTP Office of Science; Crystal Allard, CTP Office of Science; Swati Kabaria, Pharm.D., J.D., CTP Office of Compliance and Enforcement

3:15 pm – Closing Remarks 
Brittani Cushman, J.D., Turning Point (video begins at 1:41:00)
Julia McGinn-Rodriguez, M.S.P.P.M., CTP Office of Science (video begins at 1:50:00)
 


Panelists

FDA invited panelists to address information pertaining to the following topics related to tobacco product marketing application review: 

  • Application development and submission, including pre-submission meetings and use of Tobacco Product Master Files.
  • Scientific content and evaluation of PMTAs 
  • Scientific content and evaluation of Exemption Requests and SE Reports 
  • Preparation of electronic submissions including FDA resources and tools available to support application submission

Questions about your submissions?
Contact your Regulatory Health Project Manager


Additional Resources