Zdrowie i gospodarka · 5.10.2001
Guidance for Industry on Content and Format for Geriatric Labeling; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Content and Format for Geriatric Labeling." FDA established the "Geriatric use" subsection in the labeling for human prescription drug and biological products to provide pertinent information about the appropriate use of drugs in the elderly (persons aged 65 and over). This 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 the proposed labeling, the content and format for geriatric labeling supplements, and the applicability of user fees to geriatric labeling supplements.