Tobacco Products

Substantial Equivalence Reports: Manufacturer Requests for Extensions or to Change the Predicate Tobacco Product

July 2014

This draft guidance provides information to tobacco product manufacturers about FDA's policies on manufacturer requests for extensions of time to respond to deficiencies that FDA has identified, and manufacturer requests to change the predicate tobacco product, in substantial equivalence (SE) reports.


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Center for Tobacco Products
Food and Drug Administration
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Building 71, Room G335
Silver Spring, MD 20993-002

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