Guidance for Industry: Food and Drug Administration Records Access Authority Under the Federal Food, Drug, and Cosmetic Act; Availability

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The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled "FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, and Cosmetic Act." The guidance provides updated information pertaining to FDA's authority to access and copy records relating to food. It is a revision of FDA's November 2005 guidance entitled "Guidance for Industry and FDA Staff: Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Final Guidance."