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Negocios · 31/1/20191 min de lectura
Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format; Draft Guidance for Industry; Availability
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Resumen
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format." This draft guidance is intended to assist holders of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act) with their submission of required marketing status notifications.
Idioma original de la fuente: Federal Register — Food and Drug AdministrationAbrir el comunicado original →