New Tobacco Compliance Webinar Series on the SE Predicate Review Process
The U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) has received questions about how companies can improve the quality of their premarket applications under the substantial equivalence (SE) pathway. To help, FDA is launching a three-part webinar series on the SE predicate review process. The series provides an overview of predicate tobacco product reviews, in alignment with the Federal Food, Drug, and Cosmetic Act and the final rule, Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports.
FDA interprets a predicate product to mean a single tobacco product that the manufacturer will compare to its new tobacco product when it seeks to market the new tobacco product through the SE pathway.
The webinar series provides a comprehensive look at the submission and review process for a potential predicate tobacco product, including:
- Part 1: Key concepts and definitions; description of what a predicate tobacco product is under the Federal Food, Drug, and Cosmetic Act; and how the SE report review process has changed over time.
- Part 2: The submission requirements for predicate eligibility, the types of reviews CTP’s Office of Compliance (OCE) conducts, and required forms and certification statements.
- Part 3: A summary of the predicate review process, including communications from OCE, common deficiencies, changes and amendments to predicate tobacco product information, and possible outcomes of predicate reviews.
In addition to this new webinar series, FDA offers additional webinars to assist industry in complying with tobacco laws and regulations.