On November 16 , the Alliance for Aging Research submitted feedback to the Food and Drug Administration (FDA) on its recently released draft geriatric labeling guidance for human prescription drugs and biological products. The purpose of the guidance is to provide industry with recommendations on the appropriate content, format, and placement of geriatric information on drug labeling for health care practitioners.
Key points in the comment letter include:
- Older adult patients are not a homogenous group, so prescription drug labeling should include information on important geriatric subgroups. Information should also be present in multiple sections of a drug label to help healthcare professionals easily detect important clinical differences studied in a product between different age groups.
- Post-market studies are an important source of information for understanding how drugs work in the real-world for older adults. The FDA should provide clarity on the types of non-randomized clinical trial (non-RCT) data eligible for inclusion in geriatric use subsections of labels. Also, the FDA should provide information on its website to help older adults understand the differences between types of non-RCT data sources.
About the Alliance for Aging Research
The Alliance for Aging Research is the leading nonprofit organization dedicated to accelerating the pace of scientific discoveries and their application to vastly improve the universal human experience of aging and health. The Alliance believes advances in research help people live longer, happier, more productive lives and reduce healthcare costs over the long term. For more than 30 years, the Alliance has guided efforts to substantially increase funding and focus for aging at the National Institutes of Health and Food and Drug Administration; built influential coalitions to guide groundbreaking regulatory improvements for age-related diseases; and created award-winning, high-impact educational materials to improve the health and well-being of older adults and their family caregivers. For more information, visit www.agingresearch.org
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