Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format; Guidance for Industry; Availability

Streszczenie

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format." This 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. This guidance finalizes the draft guidance of the same title issued on January 31, 2019.