From: FDA
Tobacco Product Application Review; Public Meeting; Request for Comments
Docket No: FDA‐2018‐N-3504
Date: December 7, 2018
Summary: The Food and Drug Administration (FDA) is announcing a public meeting entitled “Tobacco Product Application Review.” This meeting is intended to improve public understanding and provide FDA feedback on the policies and processes for submitting and reviewing tobacco product marketing applications, including the general scientific principles relevant to various application pathways, to assist those considering submitting marketing applications for tobacco products under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
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In addition to the public meeting, FDA is opening a docket as another mechanism to receive feedback on the tobacco product application review process. Timely comments are appreciated to help inform FDA’s efforts to continue to build an efficient product review program. FDA is open to receiving feedback and comments on all aspects of the product review process and is requesting specific comment on the following topics:
- Achieving greater efficiencies in review while continuing to protect public health
○ Improving application content
○ Streamlining review processes
○ Refining electronic submission systems
- Reviewing applications for products that are rendered “new” due to changes made to comply with a product standard
- Facilitating applicant consultation with FDA prior to submitting applications
○ Types of questions that would benefit from FDA feedback
○ Meeting request and package content
○ Process from meeting request through post-meeting minutes
- Transparent review process
○ Aspects that are highly transparent
○ Aspects that are not highly transparent
○ Approaches to increase transparency
- Clarity and utility of information provided by FDA to applicants
○ Means of communicating information to applicants
○ Information that is most useful to applicants
○ Timeliness of communication