FDA Gives Guidance on Geriatric Information in Labeling

September 18, 2020

The guidance document offers information on the placement and content of geriatric information in labeling of drugs and biologics.

FDA published guidance on Sept. 15, 2020 that provides recommendations for the content and placement of geriatric information in labeling of prescription drugs. The guidance is meant to ensure consistent placement of this type of information in the correct sections and subsections in labeling so that it is clear and accessible to healthcare practitioners.

The draft guidance document replaces a withdrawn guidance, Content and Format for Geriatric Labeling (October 2001), and gives examples of geriatric use statements in labeling and examples of when FDA may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.

Source: FDA