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Data on Food and Drug Law Detailed by L. Tournas and Co-Authors (The Fountain of Youth Revisited: Regulatory Challenges and Pathways for Healthspan Promoting Interventions)

Health Policy and Law Daily

05-14-19

2019 MAY 13 (NewsRx) -- By a News Reporter-Staff News Editor at Health Policy and Law Daily -- Data detailed on Legal Issues - Food and Drug Law have been presented. According to news reporting out of Tempe, Arizona, by NewsRx editors, research stated, “For centuries, humankind has tried to evade the inevitability of aging and death by searching for the elusive fountain of youth, but the search has yielded only disappointment, false hopes, and charlatans. In the last decade or so, however, real progress has been made in the scientific understanding and modulation of the aging process.”

Our news journalists obtained a quote from the research, “This progress has come about from a new paradigm called the ‘geroscience’ hypothesis, which recognizes that aging is the number one risk factor for all chronic diseases. Therefore, there may be some intrinsic aging factors that can be targeted with interventions, rather than the futile attempt to extend healthy life by treating one chronic disease at a time. Utilizing genetic and other data showing that the aging process is malleable and can be slowed, scientists have recently identified key aging processes that underlie most chronic diseases and the symptoms of aging, such as frailty and cognitive decline. The next step has been to identify potential interventions that can affect or slow those aging processes, and a number of such candidate ‘geroprotectors’ have now been identified, mostly in animal studies but in some cases in humans. The scientific progress that has been achieved in the past decade has advanced a number of promising interventions to the point where they are now ready for human clinical trials, regulatory approval and commercialization. Yet, just as the scientific advances have made significant healthspan extension a realistic possibility for the first time in human history, regulatory and legal impediments have arisen to impede the further advancement of such interventions. Specifically, because the FDA drug approval process is based on prevention and treatment of diseases, and aging is not recognized as a ‘disease,’ there is no obvious regulatory approval pathway for therapeutics that may slow aging and extend healthspans.”

According to the news editors, the research concluded: “This paper describes this dilemma, identifies a number of alternative regulatory and commercialization pathways for healthspan extending interventions, and argues that the Food and Drug Administration (FDA) should take a more proactive role in expediting the clinical trials and regulatory approval of healthspan extension agents.”

For more information on this research see: The Fountain of Youth Revisited: Regulatory Challenges and Pathways for Healthspan Promoting Interventions. FOOD AND DRUG LAW JOURNAL, 2019;74(1):18-45. FOOD AND DRUG LAW JOURNAL can be contacted at: Food Drug Law Inst, 1000 Vermont Ave NW, Suite 1200, Washington, DC 20005-4903, USA.

Our news journalists report that additional information may be obtained by contacting L. Tournas, Asu, Ctr Law Sci & Innovat, Tempe, AZ 85281, United States.

(Our reports deliver fact-based news of research and discoveries from around the world.)

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