Guidance for Industry on Food and Drug Administration Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information; Availability

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The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information," dated September 2004. The guidance document provides to vaccine manufacturers, medical practitioners, and consumers an overview of the vaccine labeling review process, a description of FDA's review of childhood vaccine labeling, and a discussion of the type of data FDA examines when determining the adequacy of vaccine labeling.