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Entreprise · 31/01/20191 min de lecture
Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format; Draft Guidance for Industry; Availability
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Résumé
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format." This draft guidance is intended to assist holders of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) approved under the Federal Food, Drug, and Cosmetic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.
Langue originale de la source: Federal Register — Food and Drug AdministrationOuvrir le communiqué original →