Looking Toward the Next Generation of Substantial Equivalence (SE) Reports for Tobacco and Nicotine Products
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FDLI Annual Conference: Exploring Advanced Topics in Food and Drug Law
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Virtual
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As CTP works to issue decisions on thousands of products with pending PMTAs, many stakeholders anticipate a subsequent increase in SE Reports being filed. Panelists will discuss this “next generation” of SE Reports, including whether a product approved under a PMTA can be used as a predicate for an SE Report, other potential pathways for companies seeking to bring new products to market, and factors CTP should prioritize in making these decisions.

