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Over at the Life Extension Advocacy Foundation (LEAF), an argument is made that we shouldn’t be overly concerned about the current unwillingness of the FDA and similar regulatory bodies to recognize the treatment of aging and its causes as a valid indication. What is an indication? The outcome of the present overly burdensome regulatory process is formal approval of the use of a specific medical technology for a specific defined condition or set of symptoms. That condition or set of symptoms is known as an indication. Aging is not currently in the list of recognized conditions. The argument made by LEAF is that there are defined paths for rejuvenation therapies to be approved as treatments for specific age-related diseases. Thus treatments can be developed in principle, and from there the concept of off-label use applies.

Life Extension Advocacy Foundation (LEAF)FDAindicationoverly burdensome regulatory processrejuvenation therapiesoff-label use

Not classing aging as a disease is not a major problem

Not classing aging as a disease is not a major problem

Aging is a variety of distinct processes, damages, and errors; therefore, simply treating aging in clinical terms is not a viable endpoint. For a clinical trial to be conducted, it requires a verifiable indication, and aging

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