• August 12, 2020

Date set for FDA product application discussion

The US Food and Drug Administration (FDA) is inviting participation in a discussion about its policies and processes for tobacco product application review.

The meeting, at which it is not intended to communicate any new policies or interpretations regarding tobacco product marketing applications and their review, is due to be held on October 22-23 at the Tommy Douglas Conference Center in Silver Spring, Maryland.

It is due to cover a number of subjects including the general scientific principles relevant to substantial equivalence reports, exemption requests, premarket tobacco applications, and modified risk tobacco product applications.

Topics to be addressed during the meeting include:

  • An overview of the tobacco product marketing application types;
  • Information that should be included in a tobacco product marketing application;
  • Administrative processes involved in the submission and review of a tobacco product marketing application;
  • Other topics relevant to the submission of tobacco product marketing applications, including tobacco product master files, meeting requests, grandfathered review, and environmental assessments.

‘Featuring presentations from FDA staff, expert panels, and a live Q&A, this free public meeting aims to make the FDA’s tobacco product review process more efficient, predictable, and transparent,’ the FDA said in a note issued through its Center for Tobacco Products. ‘This is in keeping with the agency’s continued focus on helping industry to comply with federal tobacco regulations, while also upholding our public health mission.

‘The meeting will also be webcast live, free of charge, but registration is required. After the meeting, we will post the archived webcast and complete transcripts on the FDA website as soon as they are available.’

The FDA said that additional details, including the agenda and webcast link, would be made available closer to the meeting date.

It said it was accepting nominations for panelists interested in addressing the above topics. ‘To be considered, provide a one-page biosketch that describes and supports the individual’s expertise on the topic(s) being presented, the nature of the individual’s experience with tobacco product marketing applications and research, positions currently held, and any program development activities in which the individual has been involved,’ the note said. Nominations should be sent to workshop.CTPOS@fda.hhs.gov through August 31.

Registration should be carried out no later than September 21.