Zdrowie i gospodarka · 21.01.1999

Draft Guidance for Industry on Content and Format for Geriatric Labeling; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Content and Format for Geriatric Labeling.'' FDA established the ``Geriatric use'' subsection in the labeling for human prescription drug products in a final rule. The Geriatric use subsection includes biological drug products in order to provide for the inclusion of information pertinent to the appropriate use of drugs in the elderly (persons aged 65 and over). This draft guidance is intended to provide industry with information on submitting geriatric labeling for human prescription drug and biological products, including who should submit revised labeling, the implementation schedule, a description of the regulation and optional standard language in proposed labeling, the content and format for geriatric labeling, and the applicability of user fees to geriatric labeling supplements.