WASHINGTON -- U.S. Food & Drug Administration (FDA) has issued new guidance, "Meetings with Industry and Investigators on the Research and Development of Tobacco Products," intended for any tobacco manufacturers, importers, researchers or investigators seeking meetings with staff of the FDA's Center for Tobacco Products (CTP) regarding plans to conduct research or develop new tobacco products for marketing, the federal agency said.
The guidance is also to inform the FDA about tobacco product research intended to expand scientific knowledge needed for FDA regulation of tobacco products or to provide the data needed for premarket review requirements.
This guidance document provides industry and investigators with information related to:
- What information the FDA recommends be included in a meeting request.
- How and when to submit a request to the FDA.
- What information the FDA recommends be submitted prior to the meeting.
Click here to read the complete guidance.
And click here to view a complete list of guidance documents from the CTP.
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