Product Title and Initial U.S. Approval in Highlights for Human Prescription Drug and Biological Products-Content and Format; Draft Guidance for Industry; Availability

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products-- Content and Format." The labeling regulations for human drug and biological products require that the Highlights of Prescribing Information (Highlights) contain a product title and the year of initial U.S. approval. This draft guidance provides recommendations on the content and format of the product title and initial U.S. approval to bring greater consistency to the presentation of these required elements and to help ensure these elements provide clear and useful information to the health care provider.