Webinars

FDA’s Center for Tobacco Products (CTP) holds webinars with stakeholders to inform them of the substantial equivalence regulation and requirements. 

Recent Webinars

April 10th, 2013: 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.

• Presentation Slides: Update on Review of Substantial Equivalence Reports (SE Reports)
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Archived Webinars

August 21, 2012: 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 - Common Issues Identified During FDA’s Scientific Evaluation of Substantial Equivalence Reports

View Webinar:

• Presentation Slides: Reports on Substantial Equivalence (905(j)(1)(A)(i) Reports): An Update (PDF 331KB)
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Substantial Equivalence Reports

April 24, 2012
Presentation

• View the entire webinar 
• Reports on Substantial Equivalence (905(j)(1)(A)(i) Reports): One Year Later (Slides)
  Cristi Stark, MS, Senior Regulatory Health Project Manager, CTP Office of Science 

Small Business Follow-up

January 25, 2011
Presentations

• View the entire webinar 
• Substantial Equivalence: How the CTP Ombudsman May Be of Assistance To You (Slides)
  Les Weinstein, JD, MPA, CTP Ombudsman, CTP Office of the Director
• The Family Smoking Prevention and Tobacco Control Act’s Premarket Review Authorities: Reports on Substantial Equivalence and Exemption Requests (Slides)
  Cristi Stark, MS, Senior Regulatory Health Project Manager, CTP Office of Science 

Public Health and Tobacco Control

January 14, 2011
Presentations

• View the entire Webinar
• Substantial Equivalence: How the CTP Ombudsman May Be of Assistance To You (Slides)
  Les Weinstein, JD, MPA, CTP Ombudsman, CTP Office of the Director
• The Family Smoking Prevention and Tobacco Control Act’s Premarket Review Authorities: Reports on Substantial Equivalence and Exemption Requests (Slides)
  Cristi Stark, MS, Senior Regulatory Health Project Manager, CTP Office of Science 

Tobacco Industry: Small and Large Business

January 12, 2011
Presentations

• View the entire webinar
• Substantial Equivalence: How the CTP Ombudsman May Be of Assistance To You (Slides)
  Les Weinstein, JD, MPA, CTP Ombudsman, CTP Office of the Director
• The Family Smoking Prevention and Tobacco Control Act’s Premarket Review Authorities: Reports on Substantial Equivalence and Exemption Requests (Slides)
  Cristi Stark, MS, Senior Regulatory Health Project Manager, CTP Office of Science

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.