FDA Clarifies Purpose of Deficiency Letters Related to Premarket Review of Tobacco Product Applications
Category
Regulatory
U.S. PMTA
SOURCE: FDA Center for Tobacco Products
Date: June 11th, 2021
Time: 1:00 PM – 3:30 PM ET
Organized By: Center for Tobacco Products
Meeting Objective
This meeting was intended to provide information on the scientific review of applications received by Sept. 9, 2020. The meeting focused on the application intake process, review progress, and allocation of review resources, and included time for audience questions. The meeting was not intended to communicate any new policies or interpretations regarding tobacco product marketing applications and their review.
Agenda
This live, virtual meeting featured a presentation from CTP Office of Science Director Matt Holman and included a question and answer session with Office of Science staff.
1:00 pm – Opening Remarks and Overview of the Meeting — Anne Radway, M.S., CTP Office of Science
1:15 pm – Presentation: Deemed Product Review — Matthew R. Holman, Ph.D., Director, CTP Office of Science
2:00 pm – Question & Answer Session
Moderator: Anne Radway, M.S., CTP Office of Science
Panelists:
- Matthew R. Holman, Ph.D., Director, CTP Office of Science
- Todd L. Cecil, Ph.D., Deputy Director for Regulatory Management, CTP Office of Science
- Crystal Allard, Director, Division of Regulatory Science and Informatics (DRSI), CTP Office of Science
- Joanna C. Randazzo, D.C., Chief (Acting), Science Policy Branch, CTP Office of Science
- Cristi Stark, M.S., Director, Division of Regulatory Project Management (DRPM), CTP Office of Science
