FDA Seeks Comments on Draft Guidance

FDA has posted a draft guidance to help persons submitting applications for new tobacco products understand the premarket tobacco product application process.

The draft guidance addresses questions such as:
•    Who may submit a new tobacco product application
•    When to submit a new tobacco product application
•    What information the FD&C Act requires you to submit in a new tobacco product application
•    What information FDA recommends you submit in a new tobacco product application

The public comment period will be open for 90-days from the publication in the Federal Register.

The draft guidance can be found at:
http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm273388.htm

FDA’s Center for Tobacco Products (CTP) will hold a Webinar on Tuesday, Nov. 1 from 2 p.m. to 3 p.m. to discuss this new draft guidance.

For questions regarding the draft guidance, contact the Center for Tobacco Products (CTP) at (877) 287-1373, or by emailing AskCTP@fda.hhs.gov.

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