Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions; Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of the guidance for industry entitled "Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions." This guidance provides information in response to questions that FDA has received from manufacturers on demonstrating the substantial equivalence of a new tobacco product, including questions on when a modification to the label requires a premarket submission and review by FDA.