Geriatric Information in Human Prescription Drug and Biological Product Labeling Draft Guidance Issued by FDA
The US Food and Drug Administration (FDA) has issued draft guidance on the inclusion of Geriatric Information in Human Prescription Drug and Biological Product Labeling.
This guidance is intended to assist applicants of human prescription drug and biological products in determining the appropriate placement and content of geriatric information in labeling as described in the regulations for the content and format of labeling for human prescription drug and biological products.
The new draft guidance provides examples of specific geriatric use statements and examples of when the FDA can permit drug and biological applicants to omit or revise information that would typically be required in the “Geriatric Use” subsection of product labeling. Geriatric patients are defined as being aged 65 years and older.
This guidance, which replaces the withdrawn guidance for industry Content and Format for Geriatric Labeling (October 2001), provides additional examples of geriatric use statements in labeling and examples of when the labeling regulations authorize the FDA to permit applicants to omit or revise specific information otherwise required in the Geriatric Use subsection.
Drug sponsors must include geriatric information in the labeling when there is sufficient information to detect an efficacy and/or safety difference between younger adult patients and geriatric patients, both when there is a difference observed and when there is not. Conversely, if data is insufficient to detect efficacy and safety differences, that should be included in the label.
When a safety and/or efficacy difference is observed, sponsors should include the percentage and/or total number of patients 65 years and older and 75 years and older in clinical studies, typically the trials used for drug approval. Alternative age cutoffs may be permitted by the agency. This information should be included in the Geriatric Use section, as well as other relevant labeling sections such as Dosage and Administration, Contraindications, Warnings and Precautions, Adverse Reactions, and Clinical Studies.
When a difference is not observed or the data are insufficient to observe one, the agency recommends inclusion of the number and percentage of drug-exposed geriatric patients in certain clinical studies.
Geriatric exposure information should typically be placed at the beginning of the Geriatric Use subsection. “However, information on specific risks or safety concerns associated with the use of the drug in geriatric patients and/or recommendations on specific monitoring in geriatric patients may appear before the drug exposure information,” FDA advised.
In general, geriatric information should also be included in other sections of the labeling, as well. For instance, if a drug is approved in adults, including geriatric patients, but the dosage is different for geriatric patients, the different dosing information should appear in both the Geriatric Use and Dosage and Administration sections.
Geriatric information must also be included in the labeling when the drug is approved for a geriatric-specific indication or the drug is indicated only for use in geriatric patients. In that case, the Geriatric Use subsection would contain a summary statement and the more detailed information would be discussed throughout the rest of the labeling.
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