Meetings with Industry and Investigators on the Research and Development of Tobacco Products

Introduction:
This text is a guidance for industry and investigators on how to request meetings with the Food and Drug administration (FDa) regarding the research and development of tobacco products. The guidance provides information on how to submit a meeting request, what information to include in the request, and what to expect from FDa's response. It also outlines the process for submitting a meeting information package and the expected content of the package.

Key Points:

* Meeting requests should be submitted to the Director, Office of Science, CTP, at FDa and should include product information, a brief statement of the purpose of the meeting, a preliminary list of specific objectives/outcomes expected from the meeting, and a preliminary proposed agenda.
* FDa intends to respond to meeting requests in writing within 21 calendar days of receipt and will include the date, time, format, and location of the meeting, expected FDa participants, and instructions for submitting the meeting information package.
* Meeting information packages should include summary information relevant to the product(s) and the proposed agenda, and should be organized according to the proposed agenda. It should include product composition and design data summary, manufacturing and process control data, nonclinical data summary, clinical data summary, behavioral and product use data summary, user and non-user perception data summary, and investigational plans for studies and surveillance of the tobacco product.
* Meeting packages should be provided in electronic and paper format, and should be submitted at least 45 days prior to the scheduled meeting.
* FDa may decide to postpone or cancel a meeting if adequate supporting documentation is not provided within the designated timeframe.
* During the meeting, presentations should be limited to information included in the meeting information package.
* FDa intends to provide the official minutes of the meeting to summarize the important discussion points, decisions, recommendations, agreements, disagreements, issues for further discussion, and action items.

Main Message:
This guidance serves as a useful resource for tobacco product manufacturers, researchers, and investigators who wish to request meetings with FDa regarding the research and development of tobacco products. By following the outlined procedures and providing the necessary information, requestors can ensure a productive and informative meeting with FDa. It is essential to adhere to the designated timeframes and to provide complete and accurate information to avoid meeting postponement or cancellation. Overall, this guidance emphasizes the importance of effective communication and collaboration between tobacco product stakeholders and FDa in the development and regulation of tobacco products.

“Meetings with Industry and Investigators on the Research and Development of Tobacco Products.” FDa Center for Tobacco Products (CTP), July 2016.