Geriatric Information in Human Prescription Drug and Biological Product Labeling Guidance for Industry | FDA

Geriatric Information in Human Prescription Drug and Biological Product Labeling Guidance for Industry | FDA



FDA Issues Draft Guidance on Geriatric Information in Product Labeling

Today, the U.S. Food and Drug Administration issued the draft guidance for industry “Geriatric Information in Human Prescription Drug and Biological Product Labeling – Guidance for Industry and FDA Staff.”

This draft guidance will assist applicants of human prescription drug and biological products in determining the appropriate placement and content of geriatric use information in labeling. Geriatric patients are patients 65 years of age and older. Manufacturers should ensure the appropriate geriatric use information is consistently placed in prescription drug labeling so that the information is clear and accessible to health care professionals and guides the safe and effective use of prescription drugs in geriatric patients. This guidance also provides additional examples of geriatric use statements in labeling and replaces the withdrawn guidance for industry, Content and Format for Geriatric Labeling (October 2001).

FDA is accepting comments and suggestions on this draft guidance. For more information, please refer to docket No. FDA-2020-D-1621.