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ビジネス · 2015/3/51 分で読めます

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

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概要

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.

情報源の原言語: Federal Register — Food and Drug Administration原文の発表を開く →

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