Zdrowie i gospodarka · 06/09/2013

Draft Guidance for Industry on Specification of the Unique Facility Identifier System for Drug Establishment Registration; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration." This draft guidance specifies the UFI system for registration of domestic and foreign drug establishments. The guidance addresses provisions set forth in the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA).