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Entreprise · 05/03/20151 min de lecture
Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions; Guidance for Industry; Availability
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Résumé
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.
Langue originale de la source: Federal Register — Food and Drug AdministrationOuvrir le communiqué original →