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News|Articles|September 18, 2020
FDA Gives Guidance on Geriatric Information in Labeling
Author(s)Pharmaceutical Technology Editors
The guidance document offers information on the placement and content of geriatric information in labeling of drugs and biologics.
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FDA published
The draft guidance document replaces a withdrawn guidance, Content and Format for Geriatric Labeling (October 2001), and gives examples of geriatric use statements in labeling and examples of when FDA may permit applicants to omit or revise required information. In the document, the agency discusses labeling when a drug is approved for general use by adults, including geriatric patients; a drug is approved for geriatric-specific indications; and a drug is not approved for geriatric patient use.
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