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FDA Issues Draft Guidance on Geriatric Information in Product Labeling

On September 16, 2020, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance for industry titled “Geriatric Information in Human Prescription Drug and Biological Product Labeling.” This draft guidance will assist applicants of human prescription drug and biological products in determining the appropriate placement and content of geriatric use information in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 This guidance also provides additional examples of geriatric use statements in labeling and replaces the withdrawn guidance for industry, “Content and Format for Geriatric Labeling” (October 2001).  FDA is publishing this draft guidance to collect additional public comments. You may submit your comments regarding the draft guidance to the docket available at https://www.regulations.gov/docket?D=FDA-2020-D-1621 up to 60 days following publication in the FEDERAL REGISTER. This draft guidance, when finalized, will represent the current thinking of the FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. Your comments do make a difference and can impact the outcomes of FDA regulatory policy. Share your knowledge and experience and make your voice count.