USA – FDA releases guidance on inclusion of geriatric information in drug labeling

The US Food and Drug Administration (FDA) has issued draft guidance on the content and placement of information specific to geriatric patients in drug and biologic labeling.
 
The guidance document, issued in September 2020, replaces a previously withdrawn guidance document – “Content and Format for Geriatric Labeling” – initially released in October 2001.
 
The new draft guidance provides examples of specific geriatric use statements and examples of when the FDA can permit drug and biological applicants to omit or revise information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.
 
The new guidance urges drug sponsors not to think of geriatric patients as a “homogenous group,” since there may be differences in organ function, comorbidities, concomitant drugs, and drug distribution and elimination even among geriatric patients in different age brackets. The geriatric use statements should include information on age subgroups (such as 65-74 years, 75-84 years, and 85 years and older) when important differences exist.  (RELATED: FDA finalizes guidance on pediatric information in drug labels, Regulatory Focus, 27 March 2019)…