Webinars on SE
FDA’s Center for Tobacco Products (CTP) holds webinars with stakeholders to inform them of the substantial equivalence regulation and requirements.
- Update on Substantial Equivalence (SE) reports and a discussion of the recently published final guidance on grandfathered tobacco products.
- Draft Guidance – Substantial Equivalence Reports: Manufacturer Requests for Extensions or to Change the Predicate Tobacco Product
- Compliance Training for Small Businesses – “Substantial Equivalence - An Update”
- Compliance Training for Small Businesses – “Common Issues Identified During FDA’s Scientific Evaluation of Substantial Equivalence Reports”
- Substantial Equivalence Reports
- Small Business Follow-up
- Public Health and Tobacco Control
- Tobacco Industry: Small and Large Business
Update on Substantial Equivalence (SE) reports and a discussion of the recently published final guidance on grandfathered tobacco products.
The guidance provides information on what is needed to demonstrate that a tobacco product was commercially marketed in the United States as of February 15, 2007.
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Presentation Slides:
- Updates on Substantial Equivalence (SE) Reports and the SE Review Process
- Grandfathered Tobacco Products
Draft Guidance – Substantial Equivalence Reports: Manufacturer Requests for Extensions or to Change the Predicate Tobacco Product
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Compliance Training for Small Businesses – “Substantial Equivalence - An Update”
Due to a technical difficulty, some of the information in Ms. Cristi Stark’s section of April 10, 2013 webinar, “Substantial Equivalence: An Update” was not presented during the live broadcast. We have retaped and replaced that section of the webinar in the archived version of the broadcast to ensure that all the information we intended to convey is available.
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Presentation Slides:
Compliance Training for Small Businesses – “Common Issues Identified During FDA’s Scientific Evaluation of Substantial Equivalence Reports”
FDA has completed the scientific evaluation of numerous substantial equivalence reports and communicated our findings to the submitters of these reports. This webinar will discuss some of the recurring scientific issues that FDA has observed across many substantial equivalence reports.
Webinar Summary:
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Presentation Slides:
Substantial Equivalence Reports
Small Business Follow-up
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Public Health and Tobacco Control
Tobacco Industry: Small and Large Business
This web content highlights provisions of the Food, Drug and Cosmetic Act (FD&C Act). It is not intended to be comprehensive or reflect FDA's interpretation of the Act. For complete information, you must read the entire law. For your convenience, the section number of the FD&C Act is referenced and relevant sections are linked to throughout the web content