On October 22-23, 2018, the Food and Drug Administration will hold a public meeting on the tobacco product application review process. More information about the meeting can be found here.
The goal of the meeting is both to improve public understanding and to seek feedback regarding the tobacco product application process, including premarket tobacco applications, substantial equivalence reports, substantial equivalence exemption requests and modified risk tobacco applications. The meeting will provide an overview of the various types of tobacco product applications, discuss information to be included in those applications, address the processes involved in the review of those applications, as well as other topics relevant to the process, including meeting requests, tobacco product master files, grandfathered review and environmental assessments. The meeting will include panels of FDA and industry representatives to discuss the various topics. Bryan Haynes of Troutman Sanders will be on the panel addressing pre-submission meetings and tobacco product master files.
Stakeholders are invited to submit comments on the tobacco product application review process by December 7, 2018.
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