- Apr 2, 2009
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FDA webinar on March 24th at 2PM to delineate agencys 2007 Substantial Equivalence policy to exclude >99.9% of vapor products from SE pathway (if Deeming reg/ban is imposed), to further increase withdrawals and rejections of SE applications filed since 2011, and to NOT review SE applications filed more than 4 years ago for virtually all cigarette brands on the market.
Guidance for Industry - Demonstrating the Substantial Equivalence of a New tobacco Product: Responses to Frequently Asked Questions
FDA Tobacco Compliance Webinars?
Tobacco Product Marketing Orders
FDA reports 101 SE Orders, 43 NSE Orders, 20 Refusals to Accept letters for SE, 648 Report Withdrawals (to date) for cigarettes, RYO and smokeless tobacco products (i.e. FDA approved 101 SE Orders, rejected 711 SE applications).
Tobacco Product Marketing Orders
Guidance for Industry - Demonstrating the Substantial Equivalence of a New tobacco Product: Responses to Frequently Asked Questions
FDA Tobacco Compliance Webinars?
Tobacco Product Marketing Orders
FDA reports 101 SE Orders, 43 NSE Orders, 20 Refusals to Accept letters for SE, 648 Report Withdrawals (to date) for cigarettes, RYO and smokeless tobacco products (i.e. FDA approved 101 SE Orders, rejected 711 SE applications).
Tobacco Product Marketing Orders