FDA Premarket Application Pathways for E-Cigarettes and Other New Tobacco Products This webinar will discuss the different premarket pathways for new tobacco products, including the Premarket Tobacco Application, the Substantial Equivalence Report and the Minor Modification Exemption.
Why Should You Attend: It is critical for manufacturers and importers of cigars, pipe tobacco, electronic cigarettes, dissolvable tobacco and other novel tobacco products to be prepared to submit premarket applications to FDA to bring their products to the market. This webinar will focus on the potential FDA regulatory premarket application requirements that will apply to those products that are “deemed” to be within FDA’s authority by the upcoming Deeming Regulation. The instructor will discuss Family Smoking Prevention and Tobacco Control Act requirements, focusing on the premarket review of new and modified tobacco products under Section 910 of the Act. Areas Covered in the Webinar: Overview of the Family Smoking Prevention and Tobacco Control Act Premarket Review of New and Modified Tobacco Products Premarket Tobacco Applications Substantial Equivalence Reports Minor Modification Exemption Who Will Benefit: General Counsel and Management of tobacco companies, e-cigarette companies, etc. Regulatory Compliance Associates and Managers Medical professionals, public health and consumer advocates, and other individuals working in the smoking control/ harm reduction area Regulatory affairs professionals and scientists who work in this area Manufacturers and importers of e-cigarettes and other novel tobacco products Suppliers to Tobacco Industry
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